The prevalence of obesity in the Netherlands has also increased in recent ....
Schokker DF, Visscher TL, Nooyens AC, van Baak MA, Seidell JC. ...... In
hoofdstuk 4 werd de rol van de maagontlediging bij gewichtsverlies en ....
gedurende langere follow-up werden ook verslechtering of nieuw ontwikkelde
refluxsymptomen.
LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING
Effect on gastroesophageal reflux, esophageal motility and gastric function
Justin de Jong
Printing of this thesis was financially supported by Allergan AstraZeneca BV St. Antonius Ziekenhuis Nieuwegein Johnson & Johnson (Ethicon Endosurgery)
Laparoscopic adjustable gastric banding: Effect on gastroesophageal reflux, esophageal motility and gastric function De Jong, Justus Reinier Thesis, University Utrecht, with a summary in Dutch
ISBN: 978-90-39350874 Printed by: SENZ Grafische Media, Woerden Cover: LES TOURISTES by Elisabeth Buffoli 1989, Paris © J.R. de Jong, Utrecht 2009
LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING Effect on gastroesophageal reflux, esophageal motility and gastric function
Laparoscopische maagbandplaatsing Invloed op gastro-oesofageale reflux, oesofagusmotiliteit en maagfunctie (met een samenvatting in het Nederlands)
PROEFSCHRIFT ter verkrijging van de graad van doctor aan de Universiteit Utrecht op gezag van de rector magnificus, prof. dr. J.C. Stoof, ingevolge het besluit van het college voor promoties in het openbaar te verdedigen op donderdag 11 juni 2009 des ochtends te 10.30 uur
door Justus Reinier de Jong geboren op 9 januari 1970 te Kockengen
Promotoren:
Prof. dr. A.J.P.M. Smout Prof. dr. H.G. Gooszen
Co-promotoren: Dr. B. van Ramshorst Dr. R. Timmer
Voor mijn ouders, Scheltine, Joep, Guido en Maartje
CONTENTS
Chapter 1
General introduction and outline of the thesis
Chapter 2
The influence of laparoscopic adjustable gastric banding on gastroesophageal reflux
15
The influence of laparoscopic adjustable gastric banding on esophageal motility
27
Weight loss after laparoscopic adjustable gastric banding is not caused by altered gastric emptying
39
Chapter 5
Esophageal dilatation after laparoscopic adjustable gastric banding
47
Chapter 6
Sustained weight loss two years after laparoscopic adjustable gastric banding for morbid obesity
59
The influence of laparoscopic adjustable gastric banding on gastroesophageal reflux and esophageal motility. A systematic review
69
Chapter 8
Summary, conclusions, and future perspectives
83
Chapter 9
Samenvatting in het Nederlands
89
Dankwoord
94
Curriculum Vitae
96
Beoordelingscommissie
96
Chapter 3
Chapter 4
Chapter 7
7
Chapter 1 GENERAL INTRODUCTION AND OUTLINE OF THE THESIS
“Corpulence is not only a disease itself, but the harbinger of others” (Hippocrates)
OBESITY Obesity has increased markedly since 1980 and has reached epidemic proportions worldwide. The problems of overweight and obesity have achieved global recognition only during the past 10 years, in contrast to underweight, malnutrition, and infectious diseases, which used to be the more dominant public health issues. Among adults overweight is defined as a body mass index of 25 or greater, obesity is defined as a body mass index of 30 or greater. Among children and adolescents, overweight is defined as a body mass index for age at or above the 95th percentile of a specified reference population. In the USA in 2003–2004, 32.9% of adults 20–74 years old were obese and more than 17% of teenagers (age 12–19y) were overweight1. The prevalence of obesity in the Netherlands has also increased in recent years. According to self reported data overweight (obesity) prevalence in adult males increased from 37% (4%) in 1981 to 51% (10%) in 2004, and in adult females from 30% (6%) in 1981 to 42% (12%) in 2004, according to self-reported data. In boys and girls, obesity prevalence doubled from 1980 to 1997, and again from 1997 to 2002–2004 a two- to threefold increase was seen for almost all ages. According to the most recent data, overweight (obesity) prevalence figures range, depending on age, from 9.2% to 17.3% (2.5–4.3%) in boys, and from 14.6% to 24.6% (2.3–6.5%) in girls2. The increasing prevalence of obesity is a public health threat as it is related to chronic morbidities and disabilities such as diabetes mellitus, cardiovascular disease, nonalcoholic fatty liver disease and gastroesophageal reflux disease. Obesity is also associated with a modestly increased risk of all-cause mortality1.
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OBESITY AND GASTROESOPHAGEAL REFLUX Historical overview Already in the early seventies it was stated that excessive fat stores impair health with the mechanical burden on the abdomen being the most important factor, resulting in a predisposition for gastroesophageal reflux3. At the time, medical textbooks recommended body weight reduction as a first step in the treatment of gastroesophageal refluxin the obese patient, although these statements were not supported by objective data4. The first studies on factors influencing gastroesophageal reflux in obese patients predominantly used manometry and were carried out in the 80s. The study groups consisted mainly of patients seeking surgery for their overweight. The results of these studies were controversial and reported no difference5 6 in LES pressures or decreased LES pressures7 8 in obese subjects when compared with non-obese subjects. An increased gastroesophageal pressure gradient or increased gastric pressure in obese persons was found in many studies9 6 10 11 and the gradient was reported to decrease after weight loss6 11. Other overweight-associated abnormalities proposed were prolonged esophageal transit time10, an increase in transient relaxations of the LES12 and the presence of a hiatal hernia13. All forementioned studies did not use a reflux symptom score and often used data from other research groups as a reference for normal values. The first studies in which prolonged pH recordings were used, also yielded discrepant findings concerning the relationship between obesity and gastroesophageal reflux. In 1994, Schmitt et al. were the first to report a significant effect of weight loss brought about by diet and a fitness program on heartburn and total reflux time as measured by 24-hour pH recording14.
In 1995, a study in morbidly obese patients the prevalence of reflux symptoms and total reflux time were found not to be different from the general population15. In contrast, Rigaud described a relationship between the number of reflux episodes in 3 hours of pH monitoring and increase in waist/hip ratio, BMI and energy or fat intake16. Kjellin et al. found no influence of weight loss (10kg) in slightly obese patients (BMI 31.4) on reflux symptoms, total reflux time and LES pressure17. The difference with earlier reports is possibly caused by the limited weight loss in the slightly obese patients. Mathus-Vliegen et al reported a normal total reflux time in 17 morbidly obese patients. Weight loss and gastric distension by an intragastric balloon did not change the severity of gastroesophageal reflux18. With the increasing attention for morbid obesity and its epidemic growth an increasing number of studies on the relationship between obesity and gastroesophageal reflux have been published since 1999. With these studies the evidence for the existence of a positive relationship between gastroesophageal reflux and obesity has accumulated. In a retrospective analysis in 1389 patients excessive body weight was identified as a significant independent risk factor for hiatal hernia and excessive body weight was also significantly associated with esophagitis19. In a study evaluating 30 patients presenting for bariatric surgery, those with pathological reflux showed significantly higher body mass indices than those with physiological reflux. The same pattern was found for reflux symptoms20. In a study in 61 morbidly obese patients who were evaluated for bariatric surgery 39.3% of the patients had heartburn and/or regurgitation and 49% had an abnormal DeMeester score during pH recording21. In a group of 345 morbidly obese patients reflux symptoms were reported by 35.8% and an increased DeMeester score was found in 51.7% of the patients. Overall in 73% of the cases there was an abnormal pH monitoring. In 52.6% of the patients an hiatal hernia and in 31.4% reflux esophagitis was found during endoscopy. Esophagitis was associated with increased weight22. Recently, studies using esophageal impedance monitoring and high-resolution manometry contributed to a better understanding of the relation between gastroesophageal reflux and obesity23 24. In a study in 22 obese and 22 non-obese patients with gastroesophageal reflux, motility abnormalities were found to be more frequent and more severe in obese subjects23. Using high-resolution manometry Pandolfino et al. showed that obese subjects are more likely to have gastroesophageal junction disruption, hiatus hernia and an increased intragastric pressure and gastroesophageal pressure gradient24, supporting the more than 20 years old theory9. Wu and co-workers showed that obesity is associated with an increased incidence of transient LES relaxations and increased acid reflux during the postprandial period in subjects without GERD. They stated that abnormal postprandial LES function may be an early event in the pathogenesis of obesity-related GERD25. From 2000 to 2008, many population-based studies on the relationship between obesity and gastroesophageal reflux were performed in Europe and the USA. The majority of these studies reported a clear relationship of obesity with gastroesophageal reflux symptoms26-38. In a population-based study including 1000 participants, reflux symptoms were found to be independently associated with BMI and upper endoscopy findings were more prevalent in obese persons35. In contrast, a study in 1000 patients in the Netherlands who were referred for endoscopycould not demonstrate a significant relationship between obesity and reflux symptoms39. Finally, there is accumulating data that obesity is associated with Barrett’s esophagus and adenocarcinoma40-43. A meta-analysis published in 2005 points at an increased risk for GERD symptoms, erosive esophagitis or esophageal adenocarcinoma in subjects with overweight or obesity44.
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OBESITY SURGERY There is growing consensus that bariatric surgery is the only treatment that results in long-term sustained weight loss in individuals who have severe obesity and are at the risk for obesity-related mortality and co-morbidity45-47. The number of bariatric surgery procedures has increased significantly over the past few decades48-51. In the United States the number of bariatric surgical procedures increased from 13,386 in 1998 to 121,055 in 2004, constituting an 800% increase52. The rise in number of procedures carried out worldwide has increased from 40,000 to 146,301 procedures between 1998 and 200353. The first bariatric procedure (jejunoileal bypass) was performed in the early 1950s. The last decades have shown an evolution in operative gastrointestinal interventions including malabsorptive, malabsorptive/restrictive, restrictive and neither malabsorptive nor restrictive procedures. Prosthetics were introduced with the vertical banded gastroplasty ring or band in the early 1980s, the adjustable gastric band in the late 1980s, and the gastric pacing electrode in the late 1990s. Laparoscopy entered the field in the 1990s and dominates bariatric surgery by the 21st century45 54.
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LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING In 1978, in the USA, Wilkinson and Peloso were the first to place a nonadjustable band, consisting of 2-cm wide Marlex mesh, around the upper part of a patient’s stomach during open surgery55. In 1982, Kolle, in Norway, also described the placement of a nonadjustable gastric band during open surgery56. In 1983, Molina and Oria reported a comparable procedure, described as gastric segmentation, using a nonadjustable Dacron graft to encircle the upper stomach, resulting in a smaller pouch57. In the early nineties, Näslund, in Sweden, also performed gastric banding using Marlex mesh bands58 and Frydenburg, in Australia, initiated gastric banding with a 1.5-cm-wide silicone band reinforced with a layer of mesh59. None of these early gastric banding procedures was successful. The problem of creating a standard stoma diameter with the fixed-size nonadjustable gastric bands caused high failure rates. Complications were numerous, the most common of which were “slipping” -in which the stomach prolapsed anteriorly and posteriorly upward through the band-, band erosions and intractable vomiting and gastroesophageal reflux. Moreover, with time, the surgically created pouch gradually dilated, causing unsatisfactory weight loss. An important modification of the proximal gastric banding technique was accomplished by the Austrian surgeons Szinicz and Schnapka, who performed experiments in which they encircled the upper stomach of rabbits with a ring of silicone elastomer60. The ring contained a balloon on its inner surface, attached to a subcutaneous port. The volume of the band balloon could be adjusted by adding or removing saline via the port. In 1985, the Swedish investigators Hallberg and Forsell first described what is now known as the Swedish Adjustable Gastric Band ([SAGB] Ethicon EndoSurgery, Inc., Cincinnati, OH)61. In the same period, Kuzmak and coworkers reported the clinical use of an inflatable Silastic band, later known as the Lap-Band (Allergan Inc., Irvine, CA)62. Both the SAGB and the Lap-Band are connected to a subcutaneous port through which fluid can be added or removed to adjust the gastric stomal size. Laparoscopic insertion of the band was the next step. In 1993, Broadbent et al., in Australia, and Catona et al., in Italy, were the first to implant nonadjustable gastric bands laparoscopically63 64. In 1995, Belachew et al., working in Belgium, using laparoscopic techniques to place an adjustable gastric band65. In 1995, several investigators presented early results of laparoscopic adjustable gastric banding. By this time, both the Lap-Band and the SAGB were available for use in most parts of the world.
As gastric banding gained popularity, the bands created by Forsell and Kuzmak underwent several modifications. Kuzmak’s band, now available as the Lap-Band, was accepted for use in Europe in the mid 1990s and received approval from the U.S. Food and Drug Administration (FDA) in 2001. Forsell’s SAGB has been available in Sweden for the treatment of morbid obesity since 1987, was commercially marketed in Europe since 1996, and was approved for use in the U.S. in late 2007 as the Realize Band (Ethicon Endo-Surgery, Inc.)66. In the late 1990s it was reported that laparoscopic adjustable gastric banding resulted in a decrease of gastroesophageal reflux symptoms67-69. However, these studies were lacking objective measurements (pH recording and esophageal manometry). These prompted our prospective studies in morbidly obese patients who were candidates for laparoscopic adjustable gastric banding in the St Antonius Hospital in Nieuwegein. AIM OF THIS THESIS The aim of the studies desribed in this thesis was to assess the outcome of adjustable gastric banding and to evaluate the effects of laparoscopic adjustable gastric banding on gastroesophageal reflux and esophageal and gastric function. Chapter 2 describes a study that focused on the influence of laparoscopic adjustable gastric banding on gastroesophageal reflux. The effect of laparoscopic adjustable gastric banding on the lower esophageal sphincter and esophageal motility is reported in Chapter 3. The role of gastric emptying on weight loss after laparoscopic adjustable gastric banding is described in Chapter 4. Chapter 5 describes the effect of a study in which the influence of laparoscopic adjustable gastric banding on esophageal dilatation was evaluated. A retrospective analysis concerning the effects of laparoscopic adjustable gastric banding on weight loss in a consecutive series of 411 patients is described in Chapter 6. Chapter 7 is a systematic review of all reports on the effects of adjustable gastric banding on gastroesophageal reflux. The specific questions to be answered in this thesis were: • Does laparoscopic adjustable gastric banding affect gastroesophageal reflux? • Does laparoscopic adjustable gastric banding affect esophageal motility? • Is there a change in gastric emptying after laparoscopic adjustable gastric banding and, if so, does this contribute to the weight loss? • Does laparoscopic adjustable gastric banding cause esophageal dilatation? • Do all morbidly obese subjects benefit from adjustable gastric banding? REFERENCES 1. Ogden CL, Yanovski SZ, Carroll MD,Flegal KM. The epidemiology of obesity. Gastroenterology 2007; 132:2087-102 2. Schokker DF, Visscher TL, Nooyens AC, van Baak MA, Seidell JC. Prevalence of overweight and obesity in the Netherlands. Obes Rev 2007; 8:101-8 3. Mann GV. The influence of obesity on health. N Engl J Med 1974; 291:178-85 4. Chernow B, Castell DO. Diet and heartburn. JAMA 1979; 241:2307-8 5. O’Brien TF, Stroop EM. Lower esopageal sphincter pressure and esophageal function in obese humans. J Clin Gastroenterol 1980; 2:145-8 6. Backman L, Granstrom L, Lindahl J et al. Manometric studies of lower esophageal sphincter in extreme obesity. Acta Chir Scand 1983; 149:193-7
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7. Feldshon SD, Villar HV, Paplanus SH et al. Evaluation of cardioesophageal reflux after gastric partitioning.. Am J Gastroenterol 1983; 78:679 (abstract) 8. Hagen J, Deitel M, Khanna RK. Ilves R. Gastroesophageal reflux in the massively obese. Int Surg 1987; 72:1-3 9. Wren SF, DaCosta LR, Beck IT. Gastroesophageal pressure gradients and lower esophageal sphincter pressures in severely obese patients. Gastroenterology 1982; 82:1129 10. Mercer CD, Rue C, Hanelin L, Hill LD. Effect of obesity on esophageal transit. Am J Surg 1987; 149:177-81 11. Orlando RC, Kinard HB. Effect of morbid obesity on lower esophageal sphincter pressure. Gastroenterology 1987; 76:1212 (abstract) 12. Freidin N, Ren J, Sluss J, McCallum RW. The effect of a large meal and graded intragastric distension on transient LES relaxation frequency in normals. Gastroenterology 1988; 95:866 (abstract) 13. Stene-Larsen G, Weberg R, Froyshov Lsrsen I, Bjortuft O, Hoel B, Berstad A. Relationship of overweight to hiatus hernia and reflux oesophagitis. Scand J Gastroenterol 1988; 23:427-32 14. Schmitt CM, Brazer SR, Hamilton MA. The effect of a diet & fitness program on gastroesophageal reflux. Am J Gastroenterol 1994; 89:1626 (abstract) 15. Lundell L, Ruth M, Sanberg N, Bove-Nielsen M. Does massive obesity promote abnormal gastroesophageal reflux? Dig Dis Sci 1995; 40:1632-5 16. Rigaud D, Merrouche M, Le Moel G, Vatier J, Paycha F, Cadiot G, Naoui N, Mignon M. Factors of gastroesophageal acid reflux in severe obesity. Gastroenterol Clin Biol 1995; 19:818-25 17. Kjellin A, Ramel S, Rossner S, Thor K. Gastroesophageal reflux in obese patients is not reduced by weight reduction. Scand J Gastroenterol 1996; 31: 1047-51 18. Mathus-Vliegen LMH, Tytgat GNJ. Twenty-four-hour pH measurements in morbid obesity: effects of massive overweight, weight loss and gastric distension. Eur J Gastroenterol Hepatol 1996; 8:635-40 19. Wilson LJ, Ma W, Hirschowitz I. Association of obesity with hiatal hernia and esophagitis. Am J Gastroenterol 1999; 94:2840-4 20. Fisher BL, Pennathur A, Mutnick JL, Little AG. Obesity correlates with gastroesophageal reflux. Dig Dis Sci 1999; 44:2290-4 21. Hong D, Khajanchee YS, Pereira N, Lockhart B, Patterson EJ, Swanstrom LL. Manometric abnormalities and gastroesophageal reflux disease in the morbidly obese. Obes Surg 2004; 14:744-9 22. Suter M, Dorta G, Giusti V, Calmes JM. Gastro-esophageal reflux and esophageal motility disorders in morbidly obese patients. Obes Surg 2004; 14:959-66 23. Quiroga E, Cuenca-Abente F, Flum D, Dellinger EP, OElschlager BK. Impaired esophageal function in morbidly obese patients with gastroesophageal reflux disease: evaluation with multichannel intraluminal impedance. Surg Endosc 2006; 20:739-43 24. Pandolfino JE, El-Serag HB, Zhang Q, et al. Obesity: a challenge to esophagogastric junction integrity. Gastroenterology 2006; 130639-49 25. Wu JCY, Mui LM, Cheung CMY, Chan Y, Sung JJY. Obesity is associated with increased transient lower esophageal sphincter relaxation. Gastroenterology 2007; 132:883-889 26. Lagergren J, Bergstrom R, Nyren O. No relation between body mass and gastro-oesophageal reflux symptoms in a Swedish population based study. Gut 2000; 47: 26-29 27. Locke GR III, Talley NJ, Fett SL, Zinsmeister AR, Melton III LJ. Risk factors associated with symptoms of gastroesophageal reflux. Am J Med 1999; 106:642-9 28. Ruhl CE, Everhart JE. Overweight, but not high dietary fat intake, increases risk of gastroesphageal reflux disease hospitalization:NHANES I Epidemiologic follow up study. Ann Epidemiol 1999:424-35 29. Murray L, Johnston B, Lane A et al. Relationship between body-mass and gastro-esophageal reflux symptoms: The Bristol Helicobacter Project. Int J Epidemiol 2003; 32:645-50 30. Nilsson M, Johnsen R, Ye W, Hveem K, Lagergren J. Obesity and estrogen as risk factors for gastroesophageal reflux symptoms. JAMA 2003; 290:66-72 31. Nandurkar S, Locke GR III, Fett S et al. Relationship between body mass index, diet, excercise and gastroesophageal reflux symptoms in a community. Aliment Pharmacol Ther 2004; 20:497-505 32. Talley NJ, Quan C, Jones MP, et al. The association of upper and lower gastrointestinal tract symptoms with body mass index in an Australian cohort. Neurogastroenterol Motil 2004; 16:413-9
33. Diaz-Rubio M, Moreno-Elola-Olaso C, Rey E, Locke GR III, Rodriguez-Artalejo F Symptoms of gastroesophageal reflux: Prevalence , severity, duration and associated factors in a Spanish population. Aliment Pharmacol Ther 2004; 19:95-105 34. El-Serag HB, Graham DY, Satia JA, Rabeneck L. Obesity is an independent risk factor for GERD symptoms and erosive esophagitis. Am J Gastroenterol 2005; 100:1243-50 35. Aro P, Ronkainen J, Talley NJ, Storskrubb T, Bolling-Sterneveld E, Agreus L. Body mass index and chronic unexplained gastrointestinal symptoms: an adult endoscopic population based study. Gut 2005; 54:1377-83 36. Jacobson BC, Somers SC, Fuchs CS, et al. Body-mass index and symptoms of gastroesophageal reflux in women. N Engl J Med 2006; 354:2340-8 37. Corley DA, Kubo A, Zhao W. Abdominal obesity, ethnicity and gastroesophageal reflux symptoms. Gut 2007; 56:756-62 38. El Serag HB, Ergun GA, Pandolfino J, et al. Obesity increases oesophageal acid exposure. Gut 2007; 56:756-62 39. Van Oijen MGH, Josemanders DFGM, Laheij RJF, Van Rossum LGM, Tan ACITL, Jansen JBMJ. Gastrointestinal disorders and symptoms: does body mass index matter? Neth J Med 2006; 64:45-9 40. Freeman HJ. Risk of gastrointestinal malignancies and mechanisms of cancer development with obesity and its treatment. Best Pract Res Clin Gastroenterol 2004; 18:1167-75 41. Stein DJ, El-Serag HB, Kuczynski J et al. The association of body mass index with barrett’s esophagus. Aliment Pharmacol Ther 2005; 22:1005-10 42. El-Serag HB, Kvapil P, Hacken-Bitar J, et al. Abdominal obesity and the risk of barrett’s esophagus. Am J Gastroenterol 2005; 100:2151-6 43. Edelstein ZR, Farrow DC, Bronner MP, et al. Central adiposity and risk of barrett’s esophagus. Gastroenterology 2007133:403-11 44. Hampel H, Abraham NS, El-Serag HB. Meta-analysis: Obesity and the risk for gastroesophageal reflux disease and its complications. Ann Intern Med 2005; 143:199-211 45. Buchwald H. The future of bariatric surgery. Obes Surg 2005; 15:598–605 46. Maggard MA, Sugarman LR, Suttorp M, Maglione M., Sugerman HJ, Livingston EH, Nguyen NT, Li Z, Mojica WA, Hilton L, Rhodes S, Morton SC, Shekelle PG. Meta-analysis: surgical treatment of obesity. Ann Intern Med 2005; 142:547–559 47. Sugerman HJ, Kral JG. Evidence-based medicine reports on obesity surgery: a critique. Int J Obes 2005; 29:735–745 48. Davis MM, Slish K, Chao C, Cabana MD. National trends in bariatric surgery, 1996–2002. Arch Surg 2006; 141:71–74 49. Steinbrook R. Surgery for severe obesity. N Engl J Med 2004; 350:1075–1079 50. Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA 2005; 294:1909–1917 51. Trus TL, Pope GD, Finlayson SRG. National trends in utilization and outcomes of bariatric surgery. Surg Endosc 2005; 19:616–620 52. Zhao Y, Encinosa W. Agency for Healthcare Research and Quality AHRQ Bariatric Surgery Utilization and Outcomes in 1998 and 2004. Statistical Brief #23. January 2007 53. Buchwald H, Williams SE. Bariatric surgery worldwide 2003. Obes Surg 2004; 14:1157–1164 54. Elder KA, Wolfe BM. Bariatric Surgery: A Review of Procedures and Outcomes Gastroenterology 2007; 132:2253-2271 55. Wilkinson LH, Peloso OA. Gastric (reservoir) reduction for morbid obesity. Arch Surg 1981; 116:602–5 56. Kolle K. Gastric banding [abstract]. OMGI 7th Congress, Stockholm.1982; 145:37 57. Molina M, Oria HE. Gastric segmentation: a new, safe, effective, simple, readily revised and fully reversible surgical procedure for the correction of morbid obesity [abstract 15]. In: 6th Bariatric Surgery Colloquium; Iowa City, IA: June 2-3, 1983 58. Näslund E, Granström L, Stockeld D, Backman L. Marlex mesh gastric banding: a 7-12 year follow-up. Obes Surg 1994; 4:269 –73 59. Frydenberg HB. Modification of gastric banding, using a fundal suture. Obes Surg 1991; 1:315–7 60. Szinicz G, Mueller L, Erhard W, et al. “Reversible gastric banding” in surgical treatment of morbid obestiy0results of animal experiments. Res Exp Med (Berl) 1989; 189:55– 60
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61. Hallberg D. Forsell O. Ballongband vid behandling av massiv överwikt. Svinsk Kirurgi 1985; 344:106–8 62. Kuzmak LI. Silicone gastric banding: a simple and effective operation for morbid obesity. Contemp Surg 1986; 28:13–8 63. Broadbent R, Tracy M, Harrington P. Laparoscopic gastric banding:a preliminary report. Obes Surg 1993; 3:63–7 64. Catona A, Gossenberg M, La Manna A. Laparoscopic gastric banding:preliminary series. Obes Surg 1993; 3:207–9 65. Belachew M, Legrand M, Vincinti V, Deffechereux T, Jourdan JL, Monami B, Jacquet N. Laparoscopic placement of adjustable silicone gastric band in the treatment of morbid obesity: how to do it. Obes Surg 1995; 5:66–70 66. Steffen R. The history and role of gastric banding. Surg Obes Relat Dis 2008; 4:S7–S13 67. Niville E, Vankeirsbilck J, Dams A. Laparoscopic esophagogastric banding: a preliminary experience. Obes Surg 1998; 39-43 68. Angrisani L, Iovino P, Lorenzo M et al. Treatment of morbid obesity and gastroesophageal reflux with hiatal hernia by Lap-Band. Obes Surg 1998; 8:39-43 69. Dixon JB, O’Brien PE. Gastroesophageal reflux in obesity: the effect of Lap-Band placement. Obes Surg 1999; 9:527-31
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Chapter 2 THE INFLUENCE OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING ON GASTROOESOPHAGEAL REFLUX
JR de Jong1, B van Ramshorst1, R Timmer2, HG Gooszen3, AJPM Smout4
Departments of Surgery1 and Gastroenterology2, St Antonius Hospital Nieuwegein, Departments of Surgery3 and Gastroenterology4, University Medical Center, Utrecht, The Netherlands
Obes Surg 2004; 14:399-406
ABSTRACT Background: Laparoscopic adjustable gastric banding (LAGB) influences gastroesophageal reflux. Methods: 26 patients undergoing gastric banding were assessed by a questionnaire for symptom analysis, 24-hour pH monitoring, endoscopy and barium swallows, preoperatively, at 6 weeks and at 6 months after operation. Results: Gastric banding had minimal effect on heartburn scores but regurgitation and belching scores increased significantly during follow-up. Use of acid-reducing drugs was decreased significantly at 6 weeks and increased significantly at 6 months. Pathological reflux was present in 13 of the 26 patients preoperatively. At 6 months pathological reflux was found in only 6 of these 13 patients, but 4 of the 13 patients with preoperative normal reflux patterns had developed pathological reflux. Six months after the operation esophagitis had disappeared in 6 patients and was increased in 9 patients. In 9 patients a pouch was found at 6 months. Pouch formation was significantly correlated with the presence of pathological reflux, esophagitis and the use of acid-reducing medication. Preoperative presence of a hiatal hernia did not influence pouch formation or pathological reflux. Conclusion: LAGB decreases gastroesophageal reflux if there is no pouch formation during follow-up.
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INTRODUCTION The prevalence of morbid obesity, defined as a body mass index (BMI) > 40 kg/m2, is increasing dramatically in the Western world, leading to rising annual healthcare costs due to obesity-associated morbidity and mortality1- 3. Surgery has been shown to be the most effective treatment in selected patients to establish a long-term weight reduction, improve the quality of life and control or cure co-morbidity4- 6. In recent years laparoscopic adjustable gastric banding (LAGB) was introduced as a minimally invasive restrictive operation, and excellent results as to safety and efficacy are reported7. Although many reports include evaluation of procedure-related complications, relatively little is known about the effect of LAGB on the lower esophageal sphincter (LES) physiology and gastroesophageal reflux (GER). Some studies suggest an increase in GER after banding, whereas others report a decrease or no effect of banding on GER8-13. The influences of band position and volume on GER have remained unstudied. In this prospective study we evaluated the influence of LABG on LES physiology and GER in relation to the role of surgical technique, pouch development and pre-existent hiatal hernia. MATERIALS AND METHODS From July 1998 to March 2000, 76 consecutive morbidly obese patients underwent a LAGB procedure with the Lap-Band® System (Inamed, Santa Barbara, CA). Inclusion criteria were BMI 40kg/m2, or BMI > 35 with serious co-morbidity. All patients were thoroughly screened before surgery by a specialist panel consisting of an internist, dietician, psychologist and bariatric surgeon. Twenty-six patients out of this group (23 female and 3 male) with a mean age 41.3 (SD ± 6.4) years and mean BMI of 47.0 (SD ± 1.2) agreed to enrole in the study protocol. Written informed consent was obtained from each patient. The study was approved by the Medical Ethics Committee of St. Antonius hospital. Surgical procedure All operations were performed by one surgeon (BvR) with a large experience in laparoscopic procedures. The operation was performed according to the technique described by Belachew7 and co-
workers with the modification that the retrogastric tunnel was created high at the stomach, from the lesser curvature at or near the gastroesophageal junction to the angle of His at the greater curvature without the formation of a gastric pouch proximal to the band. To prevent band migration the gastric fundus was sutured to the proximal stomach over the anterior aspect of the band with 3 or 4 non-absorbable seromuscular sutures. The reservoir through which the band could be inflated to adjust stomal diameter was placed on the rectus sheath just below the xiphoid process. Postoperatively, all patients used a liquid diet for 4 weeks. At 6 weeks, the first stoma adjustment was carried out by filling the band with 2 ml of saline. Patients were followed at regular intervals, and further stoma adjustments were made according to each patient’s individual need, depending on the degree of weight loss. Upper GI endoscopy Upper GI endoscopy was performed before surgery and at 6 months postoperatively. Esophagitis was classified according to the classification of Savary-Miller. A hiatal hernia was diagnosed if the proximal border of the gastric folds started 2 cm proximal to the diaphragmatic impression. Barrett’s esophagus was defined as a columnar segment extending 2 cm from the proximal border of the gastric folds, which contained intestinal metaplasia on histological examination. Pouch formation A barium swallow was performed on the first postoperative day and at 6 months after the operation, to assess the position of the band in relation to the LES. A pouch was diagnosed if gastric folds or a part of the stomach was seen proximal to the band. To quantify the pouch size, a ratio was calculated between the maximum diameter of the pouch and the maximum diameter of the band. The pouch size was judged to be large if the ratio was 1. Symptom assessment To assess reflux and other upper GI symptoms the patients completed a questionnaire preoperatively, at 6 weeks and at 6 months follow-up. The questionnaire included questions about heartburn (at day- and nighttime), regurgitation, nausea and excessive belching. The intensity at which these symptoms occurred in the week before examination was scored using an ascending scale from 0 to 4 (0 = no symptoms, 1 = symptoms on 1 or 2 days, 2 = symptoms on 3 or 4 days, 3 = symptoms on 5 or 6 days and 4 = daily symptoms). The use of proton pump inhibitors (PPI), H2receptor antagonists (H2-RA), antacids and prokinetic drugs, alcohol intake (units/week) and smoking habits (number of cigarettes/day) were recorded. 24-hour pH recording An ambulatory esophageal 24-hour pH measurement was performed pre-operatively, at 6 weeks and at 6 months. Acid-reducing medication was discontinued at least 5 days prior to examination. After an overnight fast, the glass pH electrode (Mettler-Toledo, Switzerland) was placed 5 cm above the proximal border of the LES, which was determined by stationary pull-through manometry. The catheter was connected to a portable data logger (MMS, Enschede, The Netherlands). Patients were given a diary card to record drinks and meals taken during the study period. At the end of the 24-hour period, the data were downloaded to a personal computer and further analyzed using commercially available software (MMS, Enschede, The Netherlands). The analyzed parameters included the percentage of time with an esophageal pH < 4 (total, upright and supine), the number of reflux episodes, the number of reflux episodes > 5 minutes and the duration of the longest reflux episode. Gastroesophageal reflux was considered pathological when the percentage of time with oesophageal pH < 4 was 4.2 % or more.
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Statistics Data were statistically analyzed by a SPSS 8.0 package. A p-value < 0.05 was considered significant. The Mann-Whitney U test was used to compare continuous variables between unrelated groups, and the Wilcoxon Signed Ranks test was used for repeated measurements in the same patients. The Pearson correlationcoefficient was used to asses any relationship between the different variables. The Bonferroni correction was used to adjust the significance levels in multiple comparisons.
Figure 1. Grading of esophagitis according to Savary-Miller, before and 6 months after the operation 18
RESULTS The BMI (mean ± SEM) of the patients decreased from 47 ± 1.2 to 42.4 ± 1.0 at 6 weeks and to 36.7± 1.0 at 6 months (p < 0.01 for all intervals). The patients in the study group were comparable to the total group of patients operated upon in the study period with regards to age, and BMI at operation and at follow-up. Upper GI endoscopy Preoperatively, all patients underwent endoscopy. At 6 months 3 patients refused to undergo a second endoscopy. Figure 1 shows the esophagitis grading preoperatively and at 6 months follow-up. Before operation, esophagitis was found in 16 out of 26 patients (61.5%). Esophagitis was grade I in 10 patients (38.5 %) and grade II in 6 patients (23.1 %). In one patient, Barrett metaplasia was found without esophagitis. A hiatal hernia (type I) was observed in 18 patients (69.2%). Preoperatively, reflux esophagitis was significantly more frequent in patients with a hiatal hernia (p = 0.033). At 6 months esophagitis was found in 16 patients (69.5%). In 6 patients (26%), the esophagitis had disappeared, and in eight patients (35%) it was unchanged. In 9 patients (39%) the esophagitis had increased or was diagnosed for the first time. Reflux esophagitis was graded grade I in 8 patients (34.8%), grade II in 5 patients (21.7%) and grade III in 1 patient (4.3%). In 6 of the 9 patients with an increase in esophagitis a large pouch (ratio 1) was diagnosed at 6 months after the operation. Pouch development At 6 months a large pouch was found in 9 patients. In one patient, a smaller pouch was diagnosed. The mean pouch / band ratio was 1.3, with a range from 0.8 to 1.75. Five of the patients
with a pouch needed to be operated because of severe regurgitation. The band was removed and again placed in a high position without leaving a pouch proximal of the band. This resulted in disappearance of regurgitation.
Figure 2a. Frequency of daytime heartburn in individual patients preoperatively, at 6 weeks and at 6 months after operation.
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Figure 2b. The individual regurgitation scores preoperatively, at 6 weeks and at 6 months after operation.
Symptoms Preoperatively heartburn at daytime (Figure 2a) was reported by 11 patients (42.3 %). At 6 weeks the number of patients with heartburn at daytime had decreased significantly (p = 0.041) to 5 patients (19.2%). At 6 months, 6 patients (23.1%) reported heartburn at daytime. The net result at 6 months was that 8 of the 11 patients (72.7%) with heartburn at daytime preoperatively were free of symptoms and that 3 of the 15 patients (20%) without preoperative heartburn at daytime had symptoms at 6 months. Preoperatively heartburn at nighttime was reported by 2 patients (7.6%) only. At 6 weeks and 6 months there was no significant change.
Excessive belching was found preoperatively in 7 patients (26.7%); in 3 patients (11.5%), excessive belching occurred every day. At 6 weeks there was a significant increase (p = 0.015) to 14 patients (53.8%), and 8 of these patients (30.8%) reported daily belching. At 6 months there was no further increase of belching. Nausea was reported by 2 patients (7.7%) preoperatively; by 4 patients (15.4%) at 6 weeks and by 5 patients (19.2%) at 6 months. At 6 months, there was a significant difference (p = 0.043) compared with the preoperative situation. As shown in Figure 2b, the number of patients with regurgitation increased from 2 patients (7.7%) preoperatively to 4 patients (15.4%) at 6 weeks (not significant) and a significant increase to 14 patients (53.8%) at 6 months (p = 0.002). There were no statistically significant differences in symptom scores, at any point in time, between patients with a hiatal hernia preoperatively (n = 18) and those without (n = 8). Before operation acid-reducing medication was used by 10 patients (38.5%). Three patients (11.5%) used an H2-RA daily and 2 patients (7.7%) used a PPI daily. At 6 weeks only one patient needed to use an H2-RA (p = 0.007). At 6 months there was a significant increase in the use of acid-reducing medication to 19.2 % of the patients (p = 0.041). Four patients (15.4%) used a PPI and one patient (3.8%) used an H2-RA. All of these five patients had developed a pouch. Preoperatively, 5 patients smoked cigarettes (5-20, median 15) and 2 patients used alcohol (3U/day). During follow up, this did not change.
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Figure 3. Percentage of time with esophageal pH < 4 for the individual patients.
pH monitoring Analysis of pH recordings for the total patiënt group (Table 1) preoperatively and at 6 weeks revealed a decrease in number of reflux episodes for total, upright and supine position, but after Bonferroni correction for multiple comparisons, only the decrease in supine reflux episodes remained statistically significant. Other reflux variables such as the percentage of total reflux time did not change. At 6 months there were no significant differences in reflux variables compared with the pre-operative state. Analysis of the pH recordings for the individual patients showed that before operation 13 of the 26 patients had pathological reflux. At 6 weeks, 10 of these 13 patients (76.9%) showed normal reflux patterns, and 3 patients had persistent pathological reflux. Three patients of the initially
reflux-positive group without reflux at 6 weeks (33.3%) again showed pathological reflux at 6 months. At 6 months, 46.2% of the patients with preoperative pathological reflux showed a decrease in esophageal acid exposure. Twelve patients out of 13 without preoperative pathological reflux had normal reflux patterns at 6 weeks. One patient with pathological reflux at 6 weeks showed a normal reflux pattern at 6 months. At 6 months, 4 of the 11 patients (36.4%) without pathological reflux at 6 weeks showed a pathological reflux pattern. Thus, 30.1% of the patients without pathological reflux preoperatively had a pathological reflux pattern at 6 months (Figure 3).The presence of a pouch was found to be a major determinant for the presence of pathological reflux. As shown in Figure 4 and Table 2, the 9 patients with a pouch at 6 months had significantly higher esophageal acid exposure values than the patients without a pouch.
Table 1. Reflux parameters preoperatively, at 6 weeks and at 6 months after the operation.
total reflux time (%) upright reflux time (%) supine reflux time (%) reflux episodes (n) upright reflux episodes (n) supine reflux episodes (n) reflux episodes > 5min (n) upright reflux episodes > 5min (n) supine reflux episode > 5min (n) longest reflux episode upright (min) longest reflux episode supine (min)
preoperative 6 weeks
6 months
pre6wk
p-values 6wk pre6mnth 6mnth
5.2 (0.7) 6.9 (0.8) 2.3 (0.8) 38.6 (4.0) 35.3 (3.4) 3.2 (0.7) 2.4 (0.5) 1.8 (0.3) 0.6 (0.2) 7.8 (0.8) 5.5 (1.7)
7.1 (1.7) 6.5 (1.5) 7.5 (2.4) 39 (9.8) 32.9 (8.8) 6.2 (2.1) 3.6 (0.9) 1.7 (0.4) 1.9 (0.7) 12.3 (3.2) 16.7 (5.2)
NS NS NS 0.013* 0.023* 0.004 NS NS NS NS NS
NS NS 0.013* NS NS 0.022* NS NS 0.018* NS 0.015*
3.8 (1.1) 5.3 (1.5) 0.9 (0.4) 23.5 (4.7) 22.5 (4.5) 1 (0.3) 1.8 (0.8) 1.7 (0.8) 0.1 (0.1) 8.4 (2.2) 3.6 (1.8)
NS NS NS NS NS NS NS NS NS NS 0.05*
Data given as mean ± SEM, NS = not significant), *= not significant after Bonferroni correction (n = 26).
Figure 4. Mean percentage of time with esophageal pH < 4 depicted for patients with or without a pouch at 6 months follow-up.
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Correlations At 6 months the presence of a pouch was associated with esophagitis (r = 0.505, p = 0.017), use of acid-reducing medication (r = 0.427, p = 0.033), number of reflux periods in supine position (r = 0.427, p = 0.048) and total reflux time (r = 0.698, p < 0.001). Analysis of the relationship between pouch and reflux symptoms yielded a significant correlation only for day-time heartburn (r = 0.528, p = 0.007) and belching (0.472, p = 0.048). There was no significant relationship between pouch formation and the preoperative existence of a hiatal hernia. A correlation between pouch size with grade of filling of the band (mean 2.38 ± 0.07 ml) and percentage of time with esophageal pH < 4 or reflux symptoms could not be found. Smoking or the use of alcohol showed no correlation with reflux esophagitis, reflux symptoms and esophageal acid time preoperatively and during follow-up.
Table 2. Reflux parameters at 6 months
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reflux episodes (n) upright reflux episodes (n) supine reflux episodes (n) reflux episodes > 5min (n) upright reflux episodes > 5min (n) supine reflux episode > 5min (n) longest reflux episode upright (min) longest reflux episode supine (min)
Pouch + (n = 9)
Pouch – (n = 17)
p
72.9 (17.7) 58.6 (16.8) 14.3 (4.0) 7.5 (1.5) 2.8 (0.7) 4.7 (1.4) 19.0 (7.4) 40 (9.0)
15.4 (6.5) 14.8 (6.4) 0.68 (0.5) 1.0 (0.2) 0.93 (0.2) 0.06 (0.06) 7.28 (1.3) 1.1 (0.7)
0.002 0.009* < 0.001 < 0.001 0.006* < 0.001 NS < 0.001
Data given as mean ± SEM, NS = not significant), * = not significant after Bonferroni correction (n = 26). Comparison of patients with or without a pouch at 6 months after operation.
DISCUSSION This prospective follow-up study describes the influence of the Lap-Band® on the lower esophageal sphincter (LES) physiology and gastroesophageal reflux (GER). Considerable inter-individual differences in the course of symptoms and objective parameters of GER were found, as we observed patients who developed, lost and kept reflux symptoms, pathological reflux and reflux esophagitis at different follow-up intervals. Three important general observations were made: Firstly, the unfilled Lap-Band, when placed in a high esophago-gastric position is an effective antireflux device in obese patients. A significant decrease was shown in pathological reflux recordings at 6 weeks follow-up. Secondly, a clear relationship was found between pouch formation during follow-up and reflux symptoms, pathological reflux, reflux esophagitis and the use of acid-reducing drugs. Thirdly, the presence of a hiatal hernia showed no effect on the postoperative GER pattern. The influence of obesity and the influence of weight loss on GER are somewhat controversial but should be kept in mind for a correct interpretation of our results. Several reports supporting a negative effect of obesity14-17 and a positive effect of weight loss18 are available, but reports which suggest no influence can be found as well19. Most treatment regimens for GERD therefore include body weight reduction. In our study all patients lost weight, but in some reflux increased while in others reflux decreased during follow-up. The anti-reflux effect of the band was appreciated by
our patients immediately following surgery when no significant weight reduction had been achieved yet. Moreover no correlation between weight loss and reflux was found. In the literature a positive effect of the adjustable band on GER has been suggested, but mainly on clinical observations10 20. However, until now only a few objective measurements were reported. Anderson21 found a decrease in symptoms and reflux esophagitis after placement of an adjustable band. Angrisani22 found total disappearance of pathological reflux and reflux symptoms in 11 patients after adjustable gastric banding and repair of a hiatal hernia. Dixon et al.12, in a retrospective analysis, found total resolution of reflux symptoms in 75% of the patients, improvement in 15 %, no change in 6% and aggravation in 4%. They suggested the pouch as determining factor but did not perform regular upper GI series. In the only prospective study employing the Swedish band (i.e. another type of silicone adjustable gastric band) Weiss et al.23 reported pathological reflux in 34.9% of the 43 patients preoperatively and postoperative resolution of GER in all at six month follow-up. Increased GER following gastric banding has been reported by many, in some studies even leading to discontinuation of the banding method8 9 12 24 25. Westling24 found an enormous increase in reflux esophagitis from 15 % to 56 % at two years follow-up. Morino25 even found esophagitis in 60% after LAGB. In the studies published thus far it has remained unclear which factors determine whether GER and esophagitis increase or decrease after adjustable gastric banding. Is it the follow-up time, filling grade of the band, position of the band or the preoperative presence of a hiatal hernia? Our results are in accordance with the findings of Ovrebo and coworkers8 who in a series of 15 patients who underwent a non-adjustable Dacron gastric banding (without hiatal hernia repair), found an increase in heartburn and regurgitation, from 14 and 13% to 63 and 69% respectively. The total reflux time increased from 6.4% to 30.9%, which was found to be mainly because of an increase in supine reflux. It should be noted that Ovrebo et al. performed non-adjustable gastric banding procedures with the intentional formation of a pouch. In contrast, Lundell9 et al. did not find an effect of non-adjustable gastric banding on symptoms and reflux. It is unclear from the studies of Ovrebo and Lundell whether there were individual patients in whom esophageal acid exposure and symptoms improved. The anti-reflux effect of a proximally placed gastric band is likely to be caused by an augmentation of the LES by creating a longer intraabdominal pressure zone or by pulling the stomach more in the abdomen in the presence of a hiatal hernia. These mechanisms are similar to those provided by the Angelchik prosthesis12 23 26. In case of a pouch the band is not able to support the LES, and probably creates an anatomical situation comparable with hiatal hernia, favoring reflux27. The presence of a hiatal hernia is considered by some authors as a contraindication against LASGB28, but Angrisani11 reported the simultaneous succesful treatment of obesity and hiatal hernia by band placement and closing the hiatus. The significance of a concomittant hiatal hernia in pouch development is unclear and in our study no significant relationship was found. Our study shows that pouch formation is a crucial determining factor in the occurrence of GER in patients following LAGB. Development of a pouch was observed only after filling the band. The effect of pouch formation on GER stresses the importance of a meticulous surgical technique, in order to avoid pouch enlargement and fundus slippage through the band, which are reported to occur in up to 18%29. Contrary to the former technique of gastric banding with the intentional formation of a 25-30 ml pouch proximal to the band, a ‘virtually-no-pouch’ procedure is presently advocated with placement of the band at or near the gastro-esophageal junction by means of the so-called pars flaccida technique30. High placement of the band avoids tunnelling of the band through the omental bursa but instead firmly anchors the band posteriorly in the fibrous tissues at the gastroesophageal junc-
23
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tion. In combination with a number of anterior gastro-gastric sutures over the band a firm anterior and posterior fixation is realized which prevents pouch enlargement and band migration. Despite higher placement of the band, we and others observed pouch formation at 6 months, in some cases requiring surgical correction31. The most probable cause is inaccurate placement of the band. It is as yet unknown whether or not such high position of the band will lead to dilatation of the esophagus. A few reports are available in literature in which esophageal dilatation was seen in up to 71% of the patients with concomitant esophageal motility disorders23 32. The role of these disorders in gastroesophageal reflux needs to be investigated further. In our series, the grade of esophagitis increased in 39.1 % of the patients during 6 months followup; in most cases a pouch was diagnosed. In our series one case of Barrett’s esophagus was found preoperatively with an unchanged aspect at 6 months follow-up. Naslund33 found at 9 years follow-up after non-adjustable gastric banding the development of a Barrett’s esophagus in 4.3 % of the patients without clear symptomatology and despite the use of acid-reducing drugs. The observed increase of esophagitis in our study and the fact that obesity and gastroesophageal reflux are risk factors for the development af adenocarcinoma of the esophagus34 35, make endoscopic follow-up after (non)-adjustable gastric banding mandatory at present. In summary, our study has shown positive and negative effects of adjustable gastric banding on gastro-esophageal reflux. Band placement at the gastroesophageal junction has a strong antireflux effect which can be maintained at follow-up if pouch development or enlargement can be avoided. If a pouch develops by herniation of the proximal stomach through the band, an increase in pathological reflux, reflux symptoms and reflux esophagitis will be found. Long term follow-up after LAGB is absolutely necessary to evaluate the balance between positive effects such as weight loss and an antireflux effect, and negative effects such as development or deterioration of reflux disease. REFERENCES 1. Seidell JC, Deerenberg I. Obesity in Europe; prevalence and consequences for use of medical care. Pharmacoeconomics 1994; 5 (Suppl. 1):38-44 2. Colditz GA. Economic costs of severe obesity. In: Gastrointestinal surgery for severe obesity.NIH Consensus Development Conference, National Institutes of Health, Bethesda, Maryland 1991:24-30 3. Martin LF, Tan TL, Horn JR, et al. Comparison of the costs associated with medical and surgical treatment of obesity. Surgery 1995; 118:599-607 4. Brolin RE. NIH Consensus Development Panel: Gastrointestinal surgery for severe obesity. Nutrition 1996; 12:403-404 5. Naslund I, Agren G. Is obesity surgery worthwile? Obes Surg 1999; 9:326 6. Kral JG. The role of surgery in obesity management. Int J Risk Safety Med 1995; 7:111-120 7. Belachew M, Legrand M, Vincent V, et al. Laparoscopic adjustable gastric banding. World J Surg 1998; 22:955-963 8. Ovrebo KK, Hattlebak JG, Viste A, et al. Gastroesophageal reflux in morbidly obese patients treated with gastric banding or vertical banded gastroplasty. Ann Surg 1998; 228:51-58 9. Lundell L, Ruth M, Olbe L. Vertical banded gastroplasty or gastric banding for morbid obesity: effects on gastroesophageal reflux Eur J Surg 1997; 163:525-531 10. Niville E, Vankeirsbilck J, Dams A. Laparoscopic esophagogastric banding: a preliminary experience. Obes Surg 1998; 8:39-43 11. Angrisani L, Iovino P, Lorenzo M, et al. Treatment of morbid obesity and gastroesophageal reflux with hiatal hernia by Lap-Band. Obes Surg 1999; 9:396-398 12. Dixon JB, O’Brien PE. Gastroesophageal reflux in obesity: the effect of Lap-band placement. Obes Surg 1999; 9:527-531 13. Forsell P, Hallerback B, Glise H, et al. Complications following Swedish adjustable gastric banding: a long term follow-up. Obes Surg 1999; 9:11-16
14. Wilson LJ, Ma W, Hirschowitz BI. Association of obesity with hiatal hernia and esophagitis. Am J Gastroenterol 1999; 94:840-844 15. Stene Larsen G, Weberg R, Froyshov I. Relationship of overweight to hiatus hernia and reflux esophagitis. Scand J Gastroenterol 1988; 23:427-432 16. Hagen J, Deitel M, Khanna RK, et al. Gastroesophageal reflux in the massively obese. Int Surg 1987; 72:1-3 17. Fisher BL, Pennathur AA, Mutnick JL. Obesity correlates with gastroesophageal reflux. Dig Dis Sci 1999; 44:2290-2294 18. Fraser Moodie CA, Norton B, Gornall C. Weight loss has an independent beneficial effect on symptoms of gastroesophageal reflux in patients who are overweight. Scand J Gastroenterol 1999; 34:337-340 19. Kjellin A, Ramel S, Rossner S. Gastroesophageal reflux in obese patients is not reduced by weight reduction. Scand J Gastroenterol 1996; 31:1047-1051 20. O’Brien P, Brown WA, Smith A. Prospective study of laparoscopically placed adjustable gastric band in the treatment of morbid obesity. Br J Surg 1999; 85:113-118 21. Anderson P. Endoscopic and histological evaluation of the Lap-band at 12 months. Obes Surg 1999; 9:330 (abstract) 22. Angrisani L, Paola I, Santoro T. The use of Lap-band for simultaneous treatment of obesity and gastroesophageal reflux disease with or without hiatal hernia. Obes Surg 2000; 10:139 (abstract) 23. Weiss HG, Nehoda H, Labeck B, et al. Treatment of morbid obesity with laparoscopic adjustable gastric banding affects esophageal motility. Am J Surg 2000; 180:479-482 24. Westling A, Bjurling K, Ohrvall M. Silicone adjustable gastric banding: disappointing results. Obes Surg 1998; 8:467-474 25. Morino M, Toppino M, Garrone C. Disappointing long term results of laparoscopic adjustable gastric banding. Br J Surg 1997; 84:868-9 26. Bonavina L, DeMeester T, Mason R, et al. Mechanical effect of the Angelchik prosthesis on the competency of the gastric cardia: pathophysiologic implications and surgical perspectives. Dis Esoph 1997; 10:115-118 27. Kahrilas PJ. Anatomy and physiology of the gastroesophageal junction. Gastroenterol Clin N Am 1997; 26:467-485 28. Greenstein RJ, Nissan A, Jaffin B. Esophageal anatomy and function in laparoscopic gastric restrictive bariatric surgery: implications for patient selection. Obes Surg 1998; 8:199-206 29. Zimmermann JM, Blanc M, Mashoyan P, et al. Preliminary study concerning a single institution’s experience with 1410 cases of adjustable gastric banding performed from July 1995 to April 2001. Obes Surg 2001; 11:520 (abstract) 30. Catona A, La Manna L, Forsell P. Swedish adjustable gastric band: laparoscopic technique and preliminary results. Obes Surg 2000; 10:15-21 31. Niville E, Dams A. Late pouch dilation after laparoscopic adjustable gastric and esophagogastric banding: Incidence, treatment and outcome. Obes Surg 1999; 9:381-384 32. DeMaria EJ, Sugarman HJ, Meador JG, et al. High failure rate after laparoscopic adjustable silicone gastric banding for treatment of morbid obesity. Ann Surg 2001; 233:809-818 33. Naslund I, Stockeld D, Granstrom L. Six cases of Barrett’s esophagus after gastric surgery for massive obesity: an extended case report. Obes Surg 1996; 6:155-158 34. Lagergren J, Bergstrom R, Lindgren A. Symptomatic gastroesophageal reflux as risk factor for esophageal adenocarcinoma. N Eng J Med 1999; 340:825-831 35. Snook KL, Ritchie JD. Carcinoma of esophagus after adjustable gastric banding. Obes Surg 2003; 13:800-2
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Chapter 3 EFFECT OF LAPAROSCOPIC GASTRIC BANDING ON ESOPHAGEAL MOTILITY
JR de Jong*, B van Ramshorst**, R.Timmer***, HG Gooszen*, AJPM Smout****
Department of Surgery, University Medical Center, Utrecht*, Department of Surgery, St Antonius Hospital**, Nieuwegein, Department of Gastroenterology, St Antonius Hospital, Nieuwegein***, Department of Gastroenterology, University Medical Center, Utrecht****, The Netherlands
Obes Surg 2006; 16:52-8
ABSTRACT Background: Alterations in esophageal motility may occur after placement of an adjustable gastric band, as treatment for morbid obesity, near the gastroesophageal junction. It causes an outlet obstruction especially during follow up after the band is filled. Methods: 29 morbidly obese patients underwent conventional manometry preoperatively, six weeks postoperatively, before and after filling the band, and at six months postoperatively. A questionnaire was used to assess upper gastrointestinal symptoms during follow-up. Results: After band placement, there was a significant increase in lower esophageal sphincter (LES) end-expiratory pressure at 6 weeks with an empty band: 1.3 (0.9-1.9) kPa (median( interquartile range) (p = 0.003), 6 weeks with a filled band: 2.1 (1.5-2.8) kPa (p = 0.0001) and at six months: 1.5 (1.3-1.9) kPa (p = 0.001), compared to the preoperative pressure: 0.8 (0.6-1.3) kPa. Also after band placement, the high pressure zone length increased (preop 5.0 (4.3-6.0) cm vs 6 weeks 6.0 (5.0-6.5) cm. (p = 0.003). The propagation of peristaltic contractions was not significantly altered after band placement. Heartburn decreased 6 weeks postoperatively (p = 0.04) but increased at 6 months. Heartburn at 6 months was correlated with pouch formation (0.667; p < 0.01). Conclusion: Adjustable gastric band placement causes an increase in LES pressure and length of the high pressure zone. It decreases reflux symptoms in the short term, but this effect appears not to be related with an effect on LES pressure or length. Pouch formation increases reflux symptoms without having any relationship to LES pressure and length. Band placement in the short-term does not disturb propagation of esophageal contractions. 28
INTRODUCTION Laparoscopic adjustable gastric banding (LAGB) has been increasingly used to treat morbid obesity. Several short- and long-term complications have been described, such as gastric herniation or slippage, band erosion, port-site infection, gastric perforation and esophageal dilatation. Little is known about the function of the lower esophageal sphincter (LES) and the esophageal body after band placement. Because the gastric band is placed near the gastroesophageal junction, an effect of the band on the LES and/or on esophageal motility may be expected. Morbidly obese patients who were selected for bariatric surgery have shown a prevalence of asymptomatic esophageal motility disorders in 61%1. Band placement has been found to cause an increase in LES resting pressure2,3 and an impairment of LES relaxation leading to esophageal dilatation and an increase in defective contractions, not associated with an increase in dysphagia2. In contrast, Iovino et al.3 reported an increase in LES pressure, LES length and dysphagia after band placement, but found no difference in LES relaxation, peristaltic contractions and amplitude of peristaltic contraction. LES insufficiency preoperatively was related to esophageal dilatation and esophageal dysmotility after band placement 4. It has also been reported that esophageal dysmotilty was associated with pouch dilatation4,5. We hypothesized that LAGB causes increase in LES length and pressure and that LES pressure increases after filling the band, leading to an increase in dysphagia and ultimately an increase in amplitude of esophageal contractions. Therefore, a prospective follow-up study was performed to study the influence of band placement and filling of the band on LES and esophageal motility and esophageal symptoms. PATIENT AND METHODS Between July 1998 and March 2000, 76 consecutive morbidly obese patients underwent a LAGB procedure with the 10-cm Lap-Band® system (Inamed, Santa Barbara, CA, USA). Inclusion criteria
for this operation were a BMI > 40, or a BMI between 35 and 40 with serious co-morbidity (pulmonary, cardiovascular, musculoskeletal or endocrine disorders). All patients were thoroughly screened before surgery by an experienced panel consisting of an internist, a dietician, a psychologist and a bariatric surgeon. Twenty-nine patients out of this group, 26 female and three male, with a mean age of 41.3 (SD ±6.4) years and a mean BMI of 46.1 (SD ±4.8) agreed to participate in the study. Written informed consent was obtained from each patient. The study was approved by the Medical Ethics Committee of the St. Antonius Hospital. Surgery All operations were performed by one experienced laparoscopic surgeon (BvR), using the perigastric technique described by Belachew and co-workers6. To prevent band migration the gastric fundus was sutured to the proximal stomach over the anterior aspect of the band with three or four non-absorbable seromuscular sutures. The reservoir through which the band could be inflated to adjust the stomal diameter was placed on the rectus sheath just below the xiphoid process. Postoperatively, all patients took a liquid diet for 4 weeks. At 6 weeks the first stoma adjustment was carried out by filling the band with 2 ml of saline. Patients were followed at regular intervals and further stoma adjustments were made, depending on the degree of weight loss. At 6 months, the mean filling volume of the band was 2.4 ml(1.8-3.2). Symptom assessment To assess upper GI symptoms the patients completed a questionnaire preoperatively, at 6 weeks (before filling of the band) and at 6 months follow-up. The questionnaire included questions about heartburn (at day- and nighttime), regurgitation, nausea , belching and dysphagia. The intensity at which these symptoms occurred in the week prior to examination was scored using an ascending scale from 0 to 4 (0 = no symptoms, 1 = symptoms on one or two days, 2 = symptoms on three or four days, 3 = symptoms on five or six days and 4 = daily symptoms). Manometry A conventional manometry was carried out before operation, 6 weeks (before and after filling of the band) and 6 months after operation, using a water-perfused (0.5ml/min) three- lumen catheter with the side holes 5 cm apart and oriented in three different directions. The patients were measured in a supine position. Drugs with a possible effect on esophageal motility were discontinued at least five days prior to examination. A stationary pull through maneuver was done during which the catheter was withdrawn in steps of 1 cm. End-expiratory LES pressure (endexpiratory gastric pressure subtracted from actual endexpiratory pressure recording in LES channel) was measured as the mean of values from the three recording orifices. Normal range for endexpiratory LES pressure in our laboratory is 0.5-3.4 kPa. The total length of the high-pressure zone at the esophagogastric junction was measured. Thereafter, the catheter was positioned with the distal orifice 5 cm above the proximal border of the LES, and the response of the esophageal body to 10 wet swallows (5 ml of tap water at room temperature) was evaluated. The esophageal contractions were categorized in peristaltic, non-transmitted and simultaneous. The peak amplitude of the ten swallow-induced contractions was calculated for each of the three measured levels. The duration of the contractions was measured from the beginning of the upstroke to the end of the downstroke. The propagation velocity of the contraction waves was calculated from peak-to-peak intervals between peristaltic waves at adjacent side holes. When a “ramp”(pressure elevation caused by the water bolus) was present7, the ramp pressure (endexpiratory esophageal pressure subtracted from maximum ramp pressure) was determined for each recording level (proximal, mid and distal). The LES nadir pressure7 was measured for each of the LES relaxations induced by the wet swallows. A nadir pressure < 1.1 kPa (8 mmHg) was considered complete8.
29
Pouch formation A barium study of the esophagus was performed on the first postoperative day and at 6 months after operation in order to assess the position of the band in relation to the LES. A pouch was diagnosed if gastric folds or a part of the stomach were seen proximal to the band. In order to quantify the pouch size, a ratio was calculated between the maximum diameter of the pouch and the maximum diameter of the band. The pouch size was judged to be large if the ratio was 1.
dysphagia score
Statistics The data were statistically analyzed by using a SPSS 9.0 package. A p-value < 0.05 was considered to be significant. The Mann-Whitney U test was used to compare continuous variables between unrelated groups, and the Wilcoxon Signed Ranks test was used for repeated measurements in the same patients. The Spearman’s rank correlation test was used to assess relationship between the different variables. Bonferroni correction was done for multiple comparisons.
30
Figure 1. Grading of esophagitis according to Savary-Miller, before and 6 months after the operation.
RESULTS Weight loss Preoperatively Body Mass Index (BMI) was 46.1 ±4.8 kg/m2 (mean ±SD). At 6 weeks there was a significant decrease to 42.1 ±4.6 kg/m2, and at 6 months a significant decrease to 36.7 ±4.4) kg/m2 was found (p < 0.001). Symptom assessment Preoperatively heartburn at daytime was reported by 11 patients (37.9%). At 6 weeks, the number of patients with heartburn at daytime had decreased to five patients (17.2%) (p = 0.041). At 6 months, 6 patients (20.6%) reported heartburn at daytime; 8 of the 11 patients (72.7%) who had heartburn at daytime preoperatively were free of symptoms, and 3 of the 15 patients (20%) without preoperative heartburn at daytime had symptoms at six months. Preoperatively heartburn at night-time was reported by 2 patients (6.9%) only. At 6 weeks and 6 months, there was no significant change. The number of patients with regurgitation increased from 2 patients (6.9%) preoperatively to 4 patients (13.8.%) at 6 weeks (not significant) and to 14 patients (48.3%) at 6 months (p = 0.002). Dysphagia increased significantly during follow up (Figure 1), both from preoperatively to 6 weeks
LES pressure (kPa)
(p = 0.0001) and from 6 weeks to 6 months (p = 0.002). At 6 weeks 44.8% of the patients experienced dysphagia only once or twice a week, and only 6.9% had dysphagia every day. At 6 months 37.9% of the patients showed dysphagia once or twice a week and 13.8% had dysphagia every day. There were no statistically significant differences in symptom scores at any point in time, between patients with a hiatal hernia preoperatively (n = 19) and those without (n = 10)
Figure 2. End-expiratory LES pressure (kPa) in the individual patients during follow-up. 31
LES pressure There was a small but statistically significant increase in LES pressure 6 weeks after operation (empty band) compared to the preoperative pressures. Filling of the band resulted in a pronounced further increase. At 6 months, there was a significant decrease compared to six weeks after operation, but there was still a significant difference compared to the preoperative pressures. (Table 1, Figure 2). High pressure zone length The length of the high-pressure zone at the esophagogastric junction showed a significant increase after positioning of the band. This increase persisted throughout the 6 month followup.(Table 1, Figure 3). Two distinct high pressure zones (one caused by the band and one by the LES ), were seen in only one patient, who had a large pouch at 6 months postoperatively. LES nadir pressure Both placement and filling of the band caused a significant rise in LES nadir pressure (Table 1, Figure 4). There was no significant difference between 6 weeks and 6 months postoperatively. Preoperatively, LES relaxation was complete in all patients before band insufflation. After band insufflations, 4 patients had an incomplete LES relaxation. Ramp pressure The ramp pressure phenomenon was observed more often after gastric banding, and banding increased the amplitude of the ramp pressure. Filling of the band had little or no effect on ramp pressure (Table1).
0.8 (0.6-1.3)
5.0 (4.3-6.0)
100 (100-100)
0 (0-0)
10 (0-45) 0 (0-30) 30 (0-60)
1.7 (0-2.9) 0 (0-2.8) 2.9 (0-3.2)
90 (90-100) 10 (0-10) 0 0
LES endexp. pressure (kPa)
high-pressure zone length 9cm)
relaxation (%)
residual relaxation pressure (kPa)
% of swallows with ramp pressure proximal Mid Distal
ramp pressure (kPa) proximal Mid Distal
propagation (%) peristaltic simultaneous non-transmitted retrograd
preoperative
Table 1. Manometry parameters for the different intervals
100 (85-100) 0 (0-15) 0 0
2.3 (1.6-2.6) 2.6 (1.7-2.7) 3.2 (2.7-3.8)
50 (10-80) 40 (20-65) 60 (50-85)
0.3 (0.2-0.4)
72.7 (60-88.8)
6.0 (5.0-6.5)
6.0 (5.5-6.4)
1.5 (1.3-1.9)
6 months
0.003
0.003
preoperative vs 6 weeks empty
100 (100-100) 0 0 0
2.4 (1.8-2.7) 2.6 (2.4-2.9) 3.0 (2.5-3.9)
40 (12.5-80) 50 (30-70) 80 (70-100)
0.7 (0.4-0.9)
100 (80-100) 0 (0-20) 0 0
2.6 (1.9-3.0) 2.5 (1.2-2.9) 2.9 (2.8-3.3)
50 (20-90) 55 (7.5-90) 80 (62.5-100)
0.65 (0.3-0.8)
ns ns ns ns
ns 0.008 0.03*
0.007 0.0001 0.0001
0.0001
66.8 (50.9-82.4) 57.9 (48.6-75.4) 0.001
6.0 (5.7-7.0)
2.1 (1.5-2.8)
filled
empty
1.3 (0.9-1.9)
6 weeks
6 weeks
32 0.02* 0.03* ns ns
ns ns ns
ns ns 0.02*
0.0001
ns
0.03*
0.0001
vs 6 weeks filled
6 weeks empty
ns ns ns ns
0.01* 0.004 ns
0.003 0.001 0.0001
0.0001
0.0001
0.01*
0.001
vs 6 months
preoperative
3.4 (2.7-3.8) 3.5 (3.3-4.4) 3.8 (3.1-4.4)
4.2 (2.5-5.5) 4.4 (3.8-5.3)
duration contraction (s) proximal Mid Distal
velocity (cm/s) prox-mid mid-distal 2.6 (2.0-4.2) 3.8 (3.5-5.7)
3.5 (2.9-4.0) 3.9 (3.5-4.5) 4.1 (3.3-4.5)
7.1 (5.5-8.5) 11.8 (7.6-17) 14.0 (8.0-15.7)
6 weeks empty
6months
6.3 (4.4-10.8) 12.1 (7.5-17.9) 13.6 (8.9-18.6)
3.5 (3.0-4.1) 4.1 (3.4-4.3) 4.2 (3.4-4.5)
4.2 (2.3-5.2) 4.1 (3.5-5.0)
6 weeks filled
9.1 (5.4-10.2) 11.2 (6.7-14.8) 12.1 (7.4-18.6)
3.6 (3.2-4.3) 3.9 (3.4-4.3) 3.8 (3.5-4.6)
3.1 (2.4-5.7) 3.7 (2.8-4.5)
0.03* ns
ns ns ns
ns ns ns
Preoperative vs 6 weeks empty
Values expressed in median (interquartile range); ns = not significant; * = not significant after Bonferroni correction
6.9 (5.3-9.6) 12.0 (8.9-15.4) 11.5 (7.6-17.5)
amplitude peristaltic contraction (kPa) proximal Mid Distal
Preoperative
33
Preoperative
ns 0.03*
ns ns ns
0.03* ns ns
ns ns
0.03* ns 0.04*
ns ns ns
vs 6 weeks filled vs 6 months
6 weeks empty
length of high-pressure zone (cm)
Peristalsis Peak amplitudes of the esophageal contractions at the different levels were not affected by placement of the band only. Likewise, the durations of esophageal contractions remained unaltered. Propagation velocity decreased from the proximal to the mid part of the esophagus preoperatively compared to 6 weeks. There was also a decrease for the mid part to the distal part of the esophagus at six weeks after filling of the band (Table 1).
Figure 3. Length of the lower esophageal high-pressure zone (cm) in the individual patients. 34
length of high-pressure zone (cm)
Pouch development At 6 months, a large pouch was found in 9 patients. In 1 patient, a smaller pouch was diagnosed. The mean pouch / band ratio was 1.3, with a range from 0.8 to 1.75. Five of the patients with a pouch needed to be operated because of severe regurgitation. The band was removed and replaced in a higher position to leave a minimal pouch proximal to the band. This resulted in resolution of regurgitation.
Figure 4. LES nadir pressures (kPa) during follow-up in the individual patients.
Correlations Dysphagia at 6 weeks postoperatively was positively correlated with pyrosis at day-time (0.476; p = 0.009) and belching (0.539; p = 0.003) and was negatively correlated with the percentage of LES relaxation (-0.414; p = 0.04). There was no relationship between dysphagia and ramp pressure and between dysphagia and LES pressure. At 6 months a relationship was found between the presence of a pouch and heartburn at day- and night-time (0.745; p < 0.01 and 0.496; p = 0.01) and regurgitation (0.397; p = 0.04). At 6 weeks postoperatively, the LES pressure was positively correlated with the distal esophageal contraction amplitude and distal ramp pressure (0.467; p = 0.01 and 0.547; p = 0.005). At 6 weeks and 6 months postoperatively, the relaxation nadir pressure showed a positive relationship with the distal contraction amplitude (0.612; p = 0.001 and 0.550; p = 0.008). DISCUSSION In this study we examined morbidly obese subjects who underwent placement of an adjustable gastric band near or at the gastroesophageal junction. After band placement there was a significant decrease in reflux symptoms. However, a significant relationship between LES pressure, length, hiatal hernia and reflux symptoms could not be demonstrated. This may reflect the fact that the principal mechanism of reflux is transient lower esophageal sphincter relaxation (TLESR)9. Triggers of transient relaxation are gastric distension, right lateral decubitus posture and meals high in fat10. The manometric technique used in this study did not allow recording of TLESRs. After placement of the band the patients had a liquid diet for the first 6 weeks and after filling the band at 6 weeks, most of them were unable to eat large meals. These changes in eating behaviour may reduce the trigger for TLESRs and are a possible explanation for the decrease in reflux symptoms11. The formation of a pouch seemed to play a role in the postoperative increase of reflux symptoms. It is tempting to speculate the pouch functions like a hiatal hernia with stasis of acid material which can reflux to the esophagus. We found significant effects of band placement on LES characteristics, i.e. an increased sphincter pressure and length and a decreased relaxation. In contrast, no significant effect on esophageal body motility was found. In previous manometric studies performed in morbidly obese persons, LES pressures varying from 11.3 + 3.8 to 27.2 + 2.1 mmHg have been found12-18. In all but one case12 no difference with a non-obese control group was found. The LES pressures found preoperatively in this study (0.2-2.1 kPa, 1.5-15.8 mmHg) seem to be somewhat lower than those reported in the literature, but this may be due to differences in measurement technique. Our patients were comparable to literature in the sense that most patients showed a LES pressure that was within the limits of normal for our laboratory. The effect of adjustable gastric band placement on LES pressure and esophageal motility has been investigated in two studies2,3. Weiss et al2, using the Swedish band, found a significant postoperative increase of LES resting pressure and an impairment of LES relaxation. The number of esophageal contractions with defective propagation increased significantly. In contrast we found a tendency towards more effective peristaltic propagations after placement of the Lap-Band®. Iovino and coworkers2 found no difference in preoperative LES length, contraction amplitudes or duration between patients and control subjects and between patients with normal and with abnormal esophageal acid exposure. In their study postoperative manometry, performed in only 11 of the 43 patients, showed a higher mean LES pressure and an increased LES length and wave duration of esophageal contractions. No differences were found in LES relaxation, percentage of peristaltic waves and wave amplitude. In the 1970s Angelchick19 introduced a silicone prosthesis for the treatment of gastroesophageal
35
reflux. The device was placed around the distal esophagus. The adjustable gastric band is placed slightly more distal than the Angelchick prosthesis but otherwise seems comparable to it. In a study of the Angelchick prosthesis in primates a significant increase in LES pressure and LES length was found20. The authors supposed that the effect was caused by a so called posterior padding of the gastroesophageal junction, which resulted in changes in the length-tension relationship of the LES and an increased LES pressure. Bonavina et al21 found an increase in LES competence by applying the Angelchick prosthesis. They supposed the prosthesis prevented unfolding of the LES when challenged by intragastric pressure. The decrease of LES pressure we found at six months (Table 1, Figure 2) may be a sign of adaptation or weakening of the smooth muscle, because in none of the patients fluid was removed out of the band. After placement and filling of the band, there was a significant increase in ramp pressure. Mittal et al found a relationship between ramp pressure and dysphagia22, but like Mathew et al7 we did not observe such a relationship. In conclusion, this case-control study shows that in morbidly obese patients, preoperative esophageal and LES motor function are not markedly abnormal. Adjustable band placement causes an increase in LES pressure and high pressure zone length. Placement of the band decreases reflux symptoms but this effect does not appear to be related to an effect on LES pressure or length. Pouch formation increases reflux symptoms, without having any relationship to LES pressure or length. Band placement does not disturb propagation of esophageal contractions. Further studies are needed to determine whether the anti-reflux properties of the band are caused by a decrease of transient relaxations, by a change in eating pattern, or by other mechanisms. 36
REFERENCES 1. Jaffin BW, Knoepflmacher P, Greenstein R. High prevalence of asymptomatic esophageal motility disorders among morbidly obese patients. Obes Surg 1999; 9:390-5 2. Weiss HG, Nehoda H, Labeck B et al. Treatment of morbid obesity with laparoscopic adjustable gastric banding affects esophageal motility. Am J Surg 2001; 180:479-482 3. Iovino P, Angrisani L, Tremolaterra F et al. Abnormal esophageal acid exposure is common in morbidly obese patients and improves after a successful Lap-band system implantation. Surg Endosc 2002; 16:1631-5 4. Wiesner W, Hauser M, Schob et al.Pseudo-achalasia following laparoscopically placed adjustable gastric bandiing. Obes Surg 2001; 11:513-8 5. Greenstein RJ, Nissan A, Jaffin B. Esophageal anatomy and function in laparoscopic gastric restrictive bariatric surgery: implications for patient selection. Obes Surg 1998; 8:199-206 6. Belachew M, Legrand M, Vincent V, et al. Laparoscopic adjustable gastric banding. World J Surg 1998; 22:955-963 7. Mathew G, Watson DI, Myers JC et al. Oesophageal motility before and after laparoscopic Nissen fundoplication. Br J Surg 1997; 84:1465-1469 8. Castell DO, Castell JA Esophageal motilty testing. 2nd edition p. 87, Appleton & Lange, Norwalk, Connecticut 1994 9. Dent J, Dodds WJ, Friedman RH et al. Mechanism of gastroesophageal reflux in recumbent asymptomatic human subjects. J Clin Invest 1980; 65:256-67 10. Mittal RK, Balaban DH. The esophagogastric junction. N Eng J Med 1997; 336:924-932 11. Hatlebakk, Castell DO,. Obesity and gastroesophageal reflux. Motility 1998; 42:4-6 12. Angrisani L, Iovino P, Lorenzo M et al. Treatment of morbid obesity and gastroesophageal reflux with hiatal hernia by Lap-Band. Obes Surg 1999; 9:396-398 13. O ‘Brien TF, Stroop EM. Lower esophageal sphincter pressure and esophageal function in obese humans. J Clin Gastroenterol 1980; 2:145-148 14. Backman L, Granstrom L, Lindahl J et al. Manometric studies of lower esophageal sphincter in extreme obesity. Acta Chir Scand 1983; 149:193-197
15. Fisher BL, Pennathur A, Mutnick JL et al. Obesity correlates with gastroesophageal reflux. Dig Dis Sci 1999; 44:2290-4 16. Mercer CD, Wren SF, DaCosta LR et al. Gastroesophageal pressure gradients and lower esophageal sphincter pressures in severely obese patients. Gastroenterology. 1982; 82:1129 (abstract) 17. Orlando RC, Kinard HB. Effect of morbid obesity on lower esophageal sphincter pressure (LESP). Gastroenterology 1979; 76:1212 (abstract) 18. Hagen J, Deitel M, Khanna RK et al. Gastroesophageal reflux in the massively obese. Int Surg 1987; 72:1-3 19. Angelchick JP, Cohen R. A new surgical procedure for the treatment of gastroesophageal reflux and hiatal hernia. Surg Gyn Obstet 1979; 148:246-248 20. Benjamin SB, Knuff TK, Fink M et al. The Angelchik prosthesis. Effects on the lower esophageal sphincter in primates. Ann Surg 1983; 197: 63-67 21. Bonavina L, DeMeester T, Mason R et al. Mechanical effect of the Angelchik prosthesis on the competency of the gastric cardia: pathophysiologic implications and surgical perspectives. Dis Esoph 1997; 10:115-118 22. Mittal RV, Ren J, McCallum RW et al. Modulation of feline esophageal contractions by bolus volume and outflow obstruction. Am J Physiol 1990; 258:G208-15
37
Chapter 4 WEIGHT LOSS AFTER LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING IS NOT CAUSED BY ALTERED GASTRIC EMPTYING
JR de Jong1, B van Ramshorst2, HG Gooszen3, AJPM Smout4, MMC Tiel-Van Buul5
1. Dept. of Surgery, University Medical Center, Maastricht 2. Dept. of Surgery , St Antonius Hospital, Nieuwegein 3. Dept. of Surgery, University Medical Center, Utrecht 4. Dept. of Gastroenterology, University Medical Center, Utrecht 5. Dept. of Nuclear Medicine, St Antonius Hospital, Nieuwegein
Obes Surg 2009; 19:287-292
ABSTRACT Background: In order to know the role of gastric emptying in the mechanism of weight loss and early satiety after a restrictive surgical procedure for treatment of morbid obesity, a consecutive series of patients were scintigraphically investigated before and after laparoscopic adjustable gastric banding. Methods: Sixteen patients undergoing laparoscopic adjustable gastric banding underwent preoperatively and at six months postoperatively, a gastric emptying study (solid meal, single isotope). Esophageal retention time, lag phase, peak activity time, gastric emptying rate, fundus emptying rate, and weight loss were recorded. Upper GI symptom assessment was carried out by using a standardized questionnaire. Gastric emptying parameters were correlated with the upper GI symptoms. Results: Gastric band placement showed no significant influence on postoperative gastric emptying rate [median % (interquartile range): 42 (23.3-59) preoperatively vs 38 (31-71) postoperatively and fundus emptying rate: 59 (37-91) preoperatively vs 70 (53-89) postoperatively]; however, an increase in early satiety was found. Neither gastric emptying rate nor fundus emptying rate showed a relation with early satiety or weight loss. Furthermore, no correlation was found between early satiety and lag phase, esophageal retention time, start of activity, and peak activity time in proximal stomach. Conclusion: Laparoscopic adjustable gastric banding seems not to affect gastric emptying. Neither a relation between postoperative gastric emptying rate and weight loss nor between early satiety and weight loss was found. Therefore, it is unlikely that gastric emptying plays a role in the mechanism of weight loss following laparoscopic adjustable gastric banding. 40
INTRODUCTION Nowadays laparoscopic adjustable gastric banding is one of the most frequent surgical options for treatment of morbid obesity. By creating a very small gastric reservoir of the proximal stomach with a narrow opening to the distal part of the stomach, gastric banding is a so-called restrictive procedure. It results in a reduced oral intake by causing dysphagia, fullness and early satiety leading to weight loss. However, the exact mechanism of early satiety and weight loss after such restrictive procedures remains unclear. Retention of solid food in the gastric pouch with slowing of gastric emptying rate after gastroplasty has been proposed as an important factor in the mechanism of early satiety and weight loss [15]. However, others reported early satiety and weight loss after gastroplasty but did not find a significant retention in the gastric pouch or a decreased gastric emptying rate [6-8]. Further evidence for the existence of a relation between early satiety, weight loss and a change in gastric emptying rate was found in patients with functional dyspepsia [9] and in an experiment in which glucagonlike-peptide was administered to obese subjects [10]. Recently amylin, a pancreatic hormone, was found to play a role in early satiety, weight loss and to slow gastric emptying [11]. Based on the aforementioned studies, we hypothesized that gastric emptying might also play a role in early satiety and weight loss after gastric banding. Therefore, a prospective case control study was performed to study the influence of laparoscopic adjustable gastric banding on gastric emptying, weight loss and gastrointestinal symptoms. MATERIALS AND METHODS A consecutive series of 16 patients, 12 women and 4 men operated in the St. Antonius Hospital were included in the study. Their mean age was 40.5 years ( range 29-57). Their mean body mass index (BMI) was 47.8 (standard error of mean (SEM) 1.7) kg/m2. Patients with diabetes were
excluded. All patients gave written informed consent. The study protocol was approved by the Ethical Review Committee of the St. Antonius Hospital, Nieuwegein. One postoperative emptying study could not be carried out because of pregnancy. SURGERY All operations were performed by one experienced laparoscopic surgeon. The operation was performed according to the technique described by Belachew et al [12] in which the band was placed near the gastroesophageal junction leaving a minimal pouch proximal to the band. To prevent band migration, the gastric fundus was sutured to the proximal stomach over the anterior aspect of the band with three or four non-absorbable seromuscular sutures. The reservoir through which the band could be inflated to adjust the stomal diameter was placed on the rectus sheath just below the xiphoid process. Postoperatively all patients used a liquid diet for 4 weeks. At 6 weeks the first stoma adjustment was carried out by filling the band with 2 ml of saline. Patients were followed at regular intervals, and further stoma adjustments were made according to each patient’s individual need, depending on the degree of weight loss. At 6 months the mean filling grade of the band was 2.0 ml (range 1.8-2.4). GASTRIC EMPTYING SCINTIGRAPHY Gastric emptying studies using a single isotope technique [13] were performed after an overnight fast (during which the patients also refrained from smoking), before and at 6 months after laparoscopic adjustable gastric banding. In order to reduce the intraindividual variability in gastric emptying, all medication, including proton pump inhibitors and prokinetic drugs, was stopped at least 3 days prior to the study. The solid component of the meal (pancake; 350-400 kcal; 63% carbohydrate, 18% protein, 19% fat) was labeled with 12 MBq Tc-99m sulphur colloid. Patients were asked to eat the pancake within 5 minutes. If this was not possible the ingestion stopped after 5 minutes. The weight and duration of the ingested meal were noted. Immediately after start of the ingestion, scintigraphic anterior dynamic images (1 min/frame) were acquired with the patient in half sitting position over a 90-minute period using a SMV DST-Xli gamma camera connected to a dedicated computer. After the dynamic study, a static lateral image of 120 seconds was obtained immediately after drinking of 15 ml Tc-99m sulfur colloid labeled water. ANALYSIS OF SCINTIGRAPHIC GASTRIC EMPTYING Data were analysed using dedicated software (NUD HERMES, Sweden, program made by J.J.J. Born and J.Habraken, Amsterdam, The Netherlands) and were corrected for subject movement, tissue attenuation and radioactive decay. Attenuation correction was performed using a lateral correction method [14]. In the corrected images, regions of interest were drawn for the esophagus, total stomach, the proximal stomach and the intestine to calculate the gastric emptying rate and intragastric transport. The time interval between meal ingestion and the first radioactivity in the duodenum (lag phase), the post-lag emptying rate (% of the ingested meal/hour), the time of arrival of activity in the proximal stomach (min), the time of complete clearance of activity from the distal esophagus after ingestion of the meal (min), the time at which there was first peak activity in the proximal stomach (min) and the emptying rate of the proximal to the distal stomach (%/hour) were parameters of interest. Scintigraphic parameters of patients with a gastric emptying rate > 25%/hour were compared with those of patients with a gastric emptying rate < 25%/hour which was arbitrarily considered as delayed. The emptying curves of the proximal stomach were considered normal if the fundus emptying rate was > 60 %/hr.
41
SYMPTOM ASSESSMENT To assess upper GI symptoms, patients completed a questionnaire preoperatively and at 6 months follow-up. The questionnaire included questions about heartburn (at day- and nighttime), regurgitation, nausea, vomiting, belching, dysphagia and early satiety. The intensity at which these symptoms occurred in the week prior to examination was scored using an ascending scale from 0 to 4 (0 = no symptoms, 1 = symptoms on 1 or 2 days, 2 = symptoms on 3 or 4 days, 3 = symptoms on 5 or 6 days and 4 = daily symptoms). The scores were correlated with the gastric emptying parameters. STATISTICAL ANALYSIS Data were statistically analyzed by using a SPSS 12.0 package. A p-value < 0.05 was considered to be significant. The Mann-Whitney U test was used to compare continuous variables between groups, and the Wilcoxon Signed Ranks test was used for repeated measurements in the same patients. Correlation between pre- and postoperative symptoms and gastric emptying were calculated, using the Spearman’s rank correlation test for each group. Data will be presented as median and interquartile range, unless stated otherwise. Bonferroni correction was applied for multiple comparisons. RESULTS
42
WEIGHT LOSS There was a significant weight loss for the whole group from a mean BMI of 47.8 (SEM 1.6) to 41.7 (SEM 2.1) kg/m2 (p = 0.001). A relation between preoperative BMI, postoperative BMI, and weight loss with any of the gastric emptying parameters was not found. SYMPTOMS Preoperatively, heartburn was the only symptom reported (two of the 16 patients). Postoperatively, vomiting once or twice per week was found in five of the 16 patients and one patient vomited daily. Dysphagia was reported by 13 of the 16 postoperative patients. Dysphagia occurred once a week in five patients and everyday in three patients. Early satiety was experienced by 11 of the 16 postoperative patients; in all cases, this symptom occurred daily. Statistically, neither gastric emptying rate nor fundus emptying rate showed a relation with early satiety, dysphagia or weight loss. Furthermore, no correlation was found between early satiety and lag time, esophageal retention time, start of activity and peak activity time in the proximal stomach.
Table 1 Emptying parameters for the whole group of patients (n = 16)
Lag phase (min) Gastric emptying rate (%/hr) Global maximum (min) Start fundus activity (min) Fundus maximum (min) Fundus emptying rate (%/hr) Retention distal esophagus (min)
preoperative
postoperative
p-value
15.5 (9-27.7) 42 (23.3-59) 18 (10.5-25.5) 1 (1-1) 6.5 (5-17) 59 (37-91) 0 (0-3.8)
18 (4-30) 38 (31-71) 22 (8-30) 2 (1-3) 10 (7-19) 70 (53-89) 10 (3-28)
NS NS NS 0.01* NS NS 0.009*
Table 2 Emptying parameters for the group of patients with gastric emptying preoperatively > 25%/hr (n = 11)
Lag phase (min) Gastric emptying rate (%/hr) Global maximum (min) Start fundus activity (min) Fundus maximum (min) Fundus emptying rate (%/hr) Retention distal esophagus (min)
preoperative
postoperative
p-value
14 (9-28) 53 (42-81) 21 (10-26) 1 (1-1) 5 (5-20) 75 (48-107) 0 (0-5)
19.5 (6.3-34.8) 58.5 (30-104.3) 22.5 (14-31) 2.5 (1-6.5) 10 (6.8-21.8) 79 (53.5-110.5) 13.5 (2.3-33.8)
NS NS NS 0.02* NS NS NS
Table 3 Emptying parameters for the group of patients with preoperative gastric emptying < 25%/hr (n = 5)
Lag phase (min) Gastric emptying rate (%/hr) Global maximum (min) Start fundus activity (min) Fundus maximum (min) Fundus emptying rate (%/hr) Retention distal esophagus (min)
preoperative
postoperative
p-value
23 (7-39.5) 20 (17.5-23.5) 15 (11-34.5) 1 (1-2) 7 (5.5-27) 34 (28.5-59) 0 (0-12.5)
18 (3-33.5) 38 (31.5-49.5) 14 (7-37.5) 1 (1-13) 7 (6.5-30.5) 65 (49-79.5) 3 (1.5-32.5)
NS 0.04* NS NS NS NS NS
Data given as median (interquartile range) NS not significant * p value not significant after Bonferroni correction
GASTRIC EMPTYING Preoperatively, the mean amount of ingested pancake was 100.3 g (range, 76-100 g). Only three patients were not able to eat the total pancake within 5 min. Postoperatively the mean amount of ingested pancake was 83.7 g (range 28.4-114 g). Eight patients had to stop their meal at 5 min. There was no significant difference between the ingested amount of pancake pre- and postoperatively (p = 0.069). Pre- and postoperatively, no correlation between the amount of ingested pancake and the rate of gastric emptying was found. Postoperatively only a correlation was found between the amount of ingested pancake and the lag phase (-0.588, p = 0.02). When the preoperative and postoperative gastric emptying variables for the total group of patients were compared (Table 1) differences were found for the start of filling of the proximal stomach (p = 0.01) and the duration of activity remaining in the distal esophagus (p = 0.009). The former differences lost statistical difference after Bonferroni correction. Neither gastric emptying nor fundic emptying were altered significantly by band placement.(Figures 1 and 2, Table1) When divided in a group of patients with a preoperative gastric emptying rate of > 25%/h (Table 2) and a group with a preoperative gastric emptying rate < 25%/h (Table 3), no significant effect of band placement on any of the scintigraphic parameters was found.
43
Figure 1. Gastric emptying rate for individuals preoperatively and 6 months postoperatively.
Preoperatively, five of the 16 (31.3%) patients had a gastric emptying rate < 25%. In four of the five patients, there was also a fundic emptying rate < 60%. Postoperatively, all five patients showed a gastric emptying rate > 25%. Preoperatively, eight of 16 patients (50%) had a fundus emptying rate < 60%/hr. Postoperatively, in six of the eight patients the fundus emptying rates increased (Figure 2). In one patient the fundus emptying rate decreased. In four of the six patients, the increase in fundus emptying rate also resulted in an increase in gastric emptying rate to > 25%/hr. 44
Figure 2. Gastric emptying rate for individuals preoperatively and 6 months postoperatively.
DISCUSSION In the literature, controversial reports are found concerning the gastric emptying rate in morbidly obese people. Some authors claim that there is no difference in gastric emptying rate comparing with a matched control group of non-obese subjects [14,15], while others found a high emptying rate in obese subjects [16,17]. There are also reports of a delayed gastric emptying rate [18,19] like we found in about one-third of our patients preoperatively. The results of some of these studies may be influenced by not performing attenuation correction or Compton scatter [16] and only using a posterior camera [15].
In this study, in 16 morbidly obese patients, no major effect of laparoscopic gastric banding on gastric emptying was found. Therefore it is felt to be unlikely that the significant increase in vomiting and early satiety, after band placement is caused by an effect of the band on gastric emptying. The fact that no clear relationship was found between gastric emptying variables and early satiety and weight loss lends further support to this conclusion. It is likely that the effect of the surgical procedure is related to limitation in the size of the meal accompanied by early satiety caused by a decrease in accommodation of the fundus [20]. This is in agreement with two reports on the effects of vertical gastroplasty on gastric emptying [20-21]. Some studies proposed a delayed gastric emptying with prolonged satiety as an additional mechanism for weight loss [4,10]. Villar et al. [4] found a delayed gastric emptying in patients after gastroplasty but not in patients with a gastric bypass. Naslund et al. [5] observed delayed emptying after gastroplasty and after gastric bypass. Horowitz et al. [22] found a delay in emptying for solid food after gastric bypass surgery. However, in neither of these studies, a relation between the delay in gastric emptying and weight loss could be demonstrated. We also cannot confirm the existence of a relationship between BMI and gastric emptying as reported by others [18,19,23]. Early satiety that is often found after Nissen fundoplication [24-26] and partial fundoplication [27,28] is thought to be caused by delayed gastric emptying [29], while others [26] state that early satiety finds its origin in the alterations, which occur after fundoplication resulting in enhancement of gastric emptying. Gastric band placement also leads to structural changes of the proximal stomach, in particular when a fundic wrap is used to fix the band. These changes may alter the postprandial accommodation of the proximal stomach and may stimulate emptying of the fundus to the distal stomach, thereby resulting in accelerated gastric emptying. However, in our study no relationship was found between the delayed fundus- emptying rate, accelerated fundus-emptying rate, and weight loss. It is imaginable that during the placement of the band the nerve of Latarjet can be damaged, which possibly leads to changes in gastric function. Such damage of the vagal nerve may contribute to weight loss after bariatric surgery because it is accompanied by reduced sensations of hunger [30], and it decreases the intake of liquids [3]. We did not test the vagus function and we only used a solid meal. Therefore, our study does not provide additional information on the contribution of vagal dysfunction to weight loss after gastric band placement. In conclusion: Laparoscopic adjustable gastric banding does not affect gastric emptying. Furthermore, there was a relationship neither between postoperative gastric emptying rate and weight loss nor between the symptoms dysphagia, vomiting, early satiety and weight loss. It is therefore felt to be unlikely that gastric emptying plays a role in the mechanism of weight loss following laparoscopic adjustable gastric banding. REFERENCES 1. Horowitz M, Collins PJ, Chatterton BE, et al. Gastric emptying after gastroplasty for morbid obesity. Br J Surg 1984; 71:435-7 2. Gannon MX, Pears DJ, Chandler ST, et al. The effect of gastric partitioning on gastric emptying in morbidly obese patients. Br J Surg 1985; 72:952-4 3. Kral JG, Gortz L, Hermansson G, et al. Gastroplasty for obesity:long term weight loss improved by vagotomy.World J Surg 1993; 17:75-9 4. Villar HV, Wangenteen SL, Burks TF, et al. Mechanism of satiety and gastric emptying after gastric partitioning and bypass. Surgery 1981; 90:229-36 5. Naslund I, Beckman KW. Gastric emptying rate after gastric bypass and gastroplasty. Scand J Gastroenterol 1987; 22:193-201 6. Andersen T, Pedersen BH, Henriksen JH, et al. Pouch emptying of solid foods after gastroplasty for morbid obesity. Scand J Gastroenterol 1985; 20:1175-9
45
46
7. Mistiaen W, Vaneerdeweg W, Blockx P, et al. Gastric emptying rate measurement after vertical banded gastroplasty. Obes Surg 2000; 10:245-9 8. Vezina WC, Grace DM, Chamberlain MJ, et al. Gastric emptying before and after transverse gastroplasty for morbid obesity. Clin Nucl Med 1986; 11:308-12 9. Fischler B, Tack J, De Gucht V, et al. Heterogenity of symptom pattern, psychosocial factors, and pathophysiological mechanisms in severe functional dyspepsia. Gastroenterology. 2003; 124:903-10. 10. Naslund E, King N, Mansten S, et al. Prandial subcutaneous injections of glucagon-like peptide-1 cause weight loss in obese human subjects. Br J Nutr 2004; 91:439-46. 11. Reda TK, Geliebter A, Pi-Sunyer FX. Amylin, food intake and obesity. Obes Res 2002; 10:1087-9 12. Belachew M, Belva PH, Desaive C. Long-term results of laparoscopic adjustabe gastric banding for the treatment of morbid obesity. Obes Surg 2002; 564-8 13. Collins PJ, Horowitz M, Cook DJ, et al. Gastric emptying in normal subjects a reproducibltechnique using a single scintillation camera and computer system. Gut 1983; 24:1117-25 14. Ziesmann HA, Fahey FH, Atkins FB, et al. Standardization and quantification of radionuclide solid gastricemptying studies. J Nucl Med 2004; 45:760-4 15. Hutson WR, Wald A, Obesity and weight reduction do not influence gastric emptying and antral motility. Am J Gastroenterol 1993; 88:1405-9 16. Wright RA, Krinsky S, Fleeman C, et al. Gastric emptying and obesity. Gastroenterology 1983; 84:747-51 17. Tosetti C, Corinaldesi R, Stanghellini V, et al. Gastric emptying of solids in morbid obesity. Int J Obes 1996; 20:200-5 18. Maddox A, Horowitz M, Wishart J, et al. Gastric and oesophageal emptying in in obesity. Scand J Gastroenterol 1989; 24:593-8 19. Horowitz M, Collins PJ, Cook DJ, et al. Abnormalities of gastric emptying in obese patients. Int J Obes 1983; 7:415-21 20. Christian PE, Datz FL, Moore JG. Gastric emptying studies in the morbidly obese before and after gastroplasty. J Nucl Med 1986; 27:1686-90 21. Behrns KE, Soper NJ, Sarr MG, et al. Anatomic, motor and clinical assessment of vertical banded gastroplasty. Gastroenterology 1989; 97: 91-7 22. Horowitz M, Cook DJ, Collins PJ, et al. Measurements of gastric emptying after gastric bypas surgery using radionuclides. Br J Surg 1982; 69:655-7 23. Brogna A, Ferrara R, Bucceri AM, et al. Gastric emptying rates of solid food in relation to body mass index: an ultrasonographic and scintigraphic study. Eur J Radiol 1998; 27:258-63 24. Vu MK, Straathof JW, Arndt JW, et al. Motor and sensory function of the proximal stomach in reflux disease and after laparoscopic Nissen fundoplication. Am J Gastroenterol 1999; 94:1481-89 25. Swanstrom L, Wayne R. Spectrum of gastrointestinal symptoms after laparoscopic fundoplication. Am J Surg 1994; 167:538-41 26. Bais JE, Samsom M, Boudesteijn EAJ, et al.The impact of delayed gastric emptying on the outcome of antireflux surgery. Ann Surg 2001; 234:139-46 27. Lindeboom MYA, Vu MK,Ringers J, et al. Function of the proximal stomach after partial versus complete laparoscopic fundoplication. Am J Gastroenterol 2003; 98: 284-90 28. Karim SS. Comparison of total vs partial fundoplication in the management of gastroesophageal disease. Am J Surg 1997; 173: 375-8 29. Lundell LR, Myers JC, Jamieson GG. Delayed gastric emptying and its relationship to symptoms of gas bloat after antireflux surgery. Eur J Surg 1994; 160:161-6 30. Mordes JP, el Lozy M, Herrera MG, et al. Effects of vagotomy with and without pyloroplasty on weight and food intake in rats. Am J Physiol 1979; 236:61-6
Chapter 5 ESOPHAGEAL DILATATION AFTER LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING
JR de Jong1, C Tiethof2, B van Ramshorst3, HG Gooszen1, AJPM Smout3
1. Dept. of Surgery, University Medical Center, Utrecht 2. Dept. of Radiology, St Antonius Hospital, Nieuwegein 3. Dept. of Surgery , St Antonius Hospital, Nieuwegein 4. Dept. of Gastroenterology, University Medical Center, Utrecht
Accepted Surg Endosc
ABSTRACT Background: The occurrence of esophageal dilatation after laparoscopic adjustable gastric banding (LASGB) was not yet investigated systematically. Methods: Forty-five patients after LASGB were assessed for the development of esophageal dilatation by standardised barium swallow studies carried out after the operation and after a mean follow-up period of 39.3 months. The diameter of the esophagus postoperatively and during follow-up was calculated in millimeters (mm) by using the known diameter of the gastric band. An increase in diameter > 130% compared to the postoperative diameter was considered as dilatation. Symptoms were assessed by a questionnaire. In 11 patients with dilatation the band was emptied and a barium swallow performed in order to assess whether the dilatation was reversible. Results: A significant increase in the esophageal diameter (median (InterQuartileRange) was found comparing the early postoperative and follow-up data: 16.3 (14-18.7) mm vs. 20.7 (18.1-26.8)mm (p < 0.01). In 25 of the 45 patients (55.6%) the dilatation percentage exceeded 130%. In 7 of the 11 patients the dilatation after emptying of the band still exceeded 130%. The increase of esophageal diameter was significantly correlated with the duration of follow-up, with regurgitation, heartburn during nighttime, and slow esophageal clearance. Conclusion: Laparoscopic adjustable gastric banding causes esophageal dilatation in about half of the patients. This dilatation is correlated with symptoms and is partly reversible after emptying of the band. The clinical relevance of the dilatation is unclear.
48
INTRODUCTION Laparoscopic adjustable silicone gastric banding (LASGB) is an established operation in the treatment of morbid obesity. Several complications after LASGB have been described such as pouch dilatation, problems with the access port (infection and dislocation) and gastric erosion. However, it took more than ten years before a critical article was published which advised against laparoscopic adjustable gastric banding because of the high failure rate and the high incidence of esophageal dilatation (71%) accompanied by poor weight loss1. In the same year Peternac et al2 reported an incidence of esophageal dilatation of 60% after adjustable gastric banding, with a high ratio of esophageal exhaustion and impaired weight loss during long term follow-up. Until then esophageal dilatation had occasionally been reported but not mentioned as a complication. Placement of the band near the gastroesophageal junction in order to prevent the problem of pouch dilatation3 was found to decrease LES relaxation and to promote esophageal stasis and dilatation4. Wiesner et al.5 found a relation between esophageal dilatation, poor weight loss and preoperative insufficiency of the LES. More recent literature, with larger series of patients, reported commonly low percentages of esophageal dilatation6-10. Dilatation of the esophagus was in most cases the result of a small stoma size by overfilling the band but was reversible by removal of fluid out of the band. In order to assess the incidence and impact of esophageal dilatation after LASGB we Performed a study in which we analysed a cohort of patients for the development of esophageal dilatation. We tried to quantify dilatation and also assessed the relationship between esophageal dilatation and duration of follow-up, weight loss, filling of the band, symptoms, and possible reversal of the dilatation after emptying the gastric band. MATERIALS AND METHODS Forty-five out of 180 patients who underwent a LASGB procedure (Lap Band®, 9.75cm, Inamed Health, Santa Barbara, California) between January 1996 and August 1999 agreed to participate
in the study for assessment of esophageal dilatation in February 2001. The patients were randomly chosen and asked by phone to participate in the study. The group of participating patients was representative for the overall group (Table 1). In December 2007 the group of patients was again reviewed with special focus on weight loss and incidents. Written informed consent was obtained from each patient. The study was approved by the Medical Ethics Committee of the St Antonius Hospital. Outcomes were calculated for the whole group of patients and also for subgroups of patients who were operated in.1996 (n = 11), 1997 (n = 12), 1998 (n = 11) and 1999 (n = 11).
Table 1 Comparison of study group with overall group Study group (n = 45)
Overall group (n = 180)
BMI preoperative
45.1 (4.1)
45.3 (5.2)
BMI 2001
34.8 (6.2)
35.1 (7.1)
%EBL 2001
51.2
50.3
BMI 2007
35.4 (6.1)
36.0 (6.4)
%EBL 2007
48.3
46
Male (%)
4 (8.9)
23 (13)
Female (%)
41 (91.1)
154 (87)
Age (range)
36.7 (22-52)
38 (17-60)
BMI in mean (Standard Deviation). %EBL = percent of excess BMI loss compared to preoperative BMI
Diagnostic studies The patients were analyzed by repeated standardised barium swallow studies immediately after the operation and after a mean postoperative follow-up period of 39.4 (range19-64) months. The barium studies were independently analysed by two authors (JdJ, CT) and the different outcomes were discussed. Patients were asked to drink the barium continuously till the cup was empty. Clearance of the esophagus was judged radiographically and was considered delayed when most barium stayed, for at least 30 seconds, proximal to the band after finishing drinking. The diameter of the esophagus (proximal to the esophageal ampulla) postoperatively and during follow-up was calculated in millimeters (mm) by using the known diameter of the gastric band. An increase in diameter > 130%, compared to the postoperative diameter, was considered as dilatation1,11. In 11 patients of the group with esophageal dilatation > 130% (n = 25) the band was totally emptied after the barium follow-up study in order to assess the reversibility of the esophageal dilatation. One hour after emptying a second barium study was performed after which the band was filled with the original volume.
49
Symptom assessment Symptoms at follow-up were assessed by a questionnaire which was given on the same day as the barium study was performed. The questionnaire included questions about heartburn (both dayand nighttime), regurgitation and dysphagia. The intensity at which the symptoms occurred in the week prior to examination was scored using an ascending scale from 0 to 4 (0 = no symptoms, 1 = symptoms on 1 or 2 days, 2 = symptoms on 3 or 4 days, 3 = symptoms on 5 or 6 days and 4 = daily symptoms). Statistics The data were statistically analyzed by using a SPSS 12.0 package. A p-value < 0.05 was considered to be significant. The Mann-Whitney U test was used to compare continuous variables between unrelated groups, and the Wilcoxon Signed Ranks test was used for repeated measurements on the same patients. The Spearman’s rank correlation test was used to assess any relationship between the different variables.
50
Surgery All operations were performed by one surgeon (BvR). The operation was performed according to the perigastric technique, with the modification of a very small gastric pouch proximal to the band9. Postoperatively the band was left empty. All patients used a liquid diet for 4 weeks. At 6 weeks adjustments were made in the outpatient clinic if there was no weight loss. Two ml of saline was given followed by a glass of water to assure there was no outlet obstruction. The patients were followed at intervals of three months during the first year postoperatively and every six months for the next years, or earlier if there was a problem. The patients were seen by a surgeon and a nurse practicioner. Further stoma adjustments were made according to each patient’s individual needs, depending on the degree of weight loss and feeling of satiety. RESULTS A significant increase in the esophageal diameter was found comparing the early postoperative and follow-up data of the total group (p < 0.01) (Table 2). In 25 of the 45 patients (55.6%) the dilatation percentage exceeded 130%. Twelve of the 45 patients (26.7%) showed delayed claerance of esophagus. Ten of these patients had a dilatation factor > 130% (83.3%). There was no difference in the postoperative diameter between the cohorts operated on in 1996, 1997, 1998 and 1999. The diameters of the esophagus measured in 2001 showed differences between the cohorts. The largest median diameter was found for the group operated on in 1996 (Figure 1). The symptoms of the patients in the different cohorts and for the total group are listed in Table 2a. There was no significant difference between the different groups for incidence and intensity of regurgitation, heartburn and dysphagia. After initial significant weight loss found in 2001 no further weight loss was found in 2007 (Table 2). Eight of the 45 patients (17.8 %) had their gastric band removed and underwent a gastric bypass. These patients initially had succesfull weight loss after the banding procedure but showed significant weight gain on the long term (Table 2). Emptying of the band (Figure 2), carried out in 11 patients with a dilatation of more than 130%, resulted in a decrease of the dilatation. However in 7 of the 11 patients (63.6%) the dilatation percentage after emptying still exceeded 130% compared to the postoperative diameter. In the total group of patients the increase of esophageal diameter correlated significantly with duration of follow-up after primary surgery (0.465, p = 0.002), regurgitation during nighttime (0.581, p < 0.001, heartburn during daytime (0.368, p = 0.02), heartburn during nighttime (0.59,
p = 0.001), dysphagia (0.322, p = 0.046) and delayed esophageal clearance (0.550, p = 0.001). The grade of filling of the band and pouch dilatation was not correlated with esophageal dilatation.
51
Figure 1. Diameters of the esophagus postoperative and at follow-up for the different cohorts
DISCUSSION In this study, esophageal dilation was observed in a proportion of our patients who underwent LASGB. The dilatation appeared to be partly reversible after one hour by decreasing the volume of the band. The dilatation tended to increase during follow-up after the operation. The conventionel placement of a Lap Band was the perigastric method. Later, a more proximal gastric band placement with a smaller pouch was advocated to prevent pouch dilatation and gastric prolaps/slippage (esophagogastric banding and pars flaccida method)3,8. It is imaginable that in all gastric banding procedures but certainly these with a small pouch, the distal esophagus sometimes will function as a reservoir for solid food especially when the band is filled during follow-up. This fact possibly contributes to the development of esophageal dilatation postoperatively. There is little evidence that different techniques of band placement influence esophageal dilatation. Weiss et al.4 found a high incidence of esophageal dilatation after esophagogastric banding3 compared to classical gastric banding. Previously, esophageal dilatation found in barium studies have been reported in literature, with an incidence ranging from 0.5% to 77.9 %4-18 (Table 3). A few reports mention esophageal dilatation as one of the reasons to reoperate after LASGB (1.8 to 4.1 % of the reoperations)10,13,14. However, it is unclear in most reports whether all patients had barium follow-up studies and how esophageal dilatation was defined. Therefore, it is difficult to compare these differences in outcome.
15.1 (13.6-18.7)
28.4 (18.5-31.9)#
170 (124.8-189.5)*
60 (51-64)
47.7
52.6
n = 11
esoph. diameter postop (mm)
esoph. diameter 2001 (mm)
dilatation (%)
follow-up 2001 (months)
% EBL 2001
% EBL 2007
gastric bypass n = 3
4.4 (3.4-4.6)
band volume 2007(ml)
reinterventions 2001-2007
3.4 (2.8-4.0)
band volume 2001 (ml)
slippage n = 4 port n = 2
n = 12
34.5 (30.8-41.3)
BMI 2007
reinterventions postop-2001
50.3
35.3 (31.6-38.4)
BMI 2001
port n = 1
gastric bypass n = 2
slippage n = 3 port n = 1
49.8
42.5 (41-47)
129.2 (97.3-156)
22.8 (19.8-31.2)
17.9 (15.7-21.7)
3.0 (2.3-3.4)
2.5 (2.0-3.4)
33.8 (30.3-39.1)
32.9 (30-44.8)
44.6 (42.9-47.7)
45 (42.5-46.1)
BMI preop (kg/m2)
1997
1996
Cohort
Table 2. Parameters of the different cohorts and of the total group of patients
gastric bypass n = 1 slippage n = 4 slippage n = 4
slippage n = 3 port n = 1
n = 11
42
58.5
32 (29-35)
136.6 (114.5-152.6)*
20.2 (18.1-24.6)
16.3 (14.1-18.2)
3.2 (2.9-3.7)
3 (2.4-3.4)
35.1 (33.6-40.7)
32.4 (31.2-36.2)
44.3 (43-49)
1998
52 slippage n = 2
gastric bypass n = 2
slippage n = 1
n = 11
44.8
49.3
24 (23-25)
110.4 (103-155.5)*
18.0 (16.3-20.1)#
15.5 (13.2-18.7)
2.8 (2.6-3.8)
3.0 (1.8-4.0)
34.7 (31.7-38.7)
34.1 (29.2-40)
43 (40-51)
1999
port n = 1
gastric bypass n = 8
slippage n = 11 port n = 4
n = 45
47.4
51.3
40 (26.5-49)
136.1 (107.5-162.2)
20.7 (18.1-26.8)
16.3 (14-18.7)
3.2 (2.6-3.8)
3.2 (2.2-3.6)
34.7 (31.6-39.3)
33.7 (30.8-38.7)
44.4 (42.5-47.7)
total group
diameter of esophagus (mm) Figure 2. The change of the esophageal diameter after deflation of the gastric band
Table 3 Symptoms reported by patients in the week prior to the barium study at follow-up.
53
Heartburn
daytime
nighttime
Intensity
0
1
2
3
4
0
1
2
3
4
1996 (n = 11)
7
2
1
0
1
6
1
2
1
1
1997 (n = 12)
6
3
1
0
2
8
4
0
0
0
1998 (n = 11)
8
2
0
0
1
10
1
0
0
0
1999 (n = 11)
6
4
0
0
1
8
1
1
0
1
Regurgitation
daytime
Intensity
0
1
2
3
4
0
1
2
3
4
1996 (n = 11)
7
4
0
0
0
7
0
4
0
0
1997 (n = 12)
10
1
0
1
0
10
1
1
0
0
1998 (n = 11)
10
1
0
0
0
10
1
0
0
0
1999 (n = 11)
8
2
0
0
1
9
1
0
0
1
nighttime
Dysphagia Intensity
0
1
2
3
4
1996 (n = 11)
3
6
1
1
0
1997 (n = 12)
5
5
2
0
0
1998 (n = 11)
3
4
1
1
2
1999 (n = 11)
5
4
1
0
1
Data in numbers of patients. 0 = no symptoms, 1 = 1or 2 days, 3 = 3 or 4 days, 4 = every day
54
The problem in quantifying esophageal dilatation is that there is no standard measurement for esophageal dilatation by contrast esophagography11. Another problem is the definition of normal or pathologic dilatation. Dargent proposed a system for analysing and discriminating different stages of esophageal dilatation. He reported esophageal dilatation as a common finding following gastric banding but irreversible esophageal dilatation was rare10. However he did not support his proposal with clear data. The question is whether the different stages of dilatation are clear and reproducible because radiological interpretations can be considered subjective11. Fielding et al. found, in his series of 1234 patients, esophageal dilatation in one patient after long term follow-up examinations which were performed on only 34 patients8. Neither a definition nor criteria to diagnose dilatation were reported. It is also unclear whether these 34 patients were representative for the overall group of patients. Lew and co-workers found an increase in esophageal diameter of 4 mm after 6 months and another 4 mm after 12 months. However, the percentage of patients without dilatation was not given19. Milone et al. reported esophageal dilatation after one year in 14% of their patients. They used a diameter of 35 mm as a cutoff point for dilatation20. Using this reference point we would have only two patients ( 4.4% instead of 55.6%) with esophageal dilatation. This fact shows the difficulty of interpreting the reported percentages of dilatation by using different definitions of esophageal dilatation. We did not perform esophagography preoperatively therefore we were only able to compare the barium studies taken 24 hour postoperatively with the follow-up studies. There is no evidence in literature that the gastric banding procedure itself has a negative or positive influence on the esophageal diameter seen in a barium swallow study. But it is imaginable that a band, placed more or less tightly around the stomach, causes a relative outlet obstruction, resulting in more stretching of the esophagus. Therefore our postoperative esophageal diameter could be already increased, compared to the preoperative diameter. Despite these considerations an increase of diameter during follow-up was found. The study of DeMaria and co-workers1 was the first recorded study which focused on esophageal dilatation after laparoscopic adjustable gastric banding. They found a dilatation of the esophagus in 71% (18 of 25 patients) which was accompanied by lower weight loss. They found dilatation only in patients with a follow–up of at least one year. However, this study was one in the so called
trial-A in order to get FDA approval for use of the Lap Band in the US. In this study the poor results were possibly caused by the learning curve and adjustment policy. If esophageal dilatation occurs, the strategy is to empty the band temporarily, which will result in a decrease in esophageal diameter with a better passage of food, but also in weight gain. Slowly refilling is advocated8 but return of dilatation is not excluded. Esophageal dilatation related to follow-up duration was also reported by others16.
Table 4 Percentages of esophageal dilatation reported in literature.
Author
year
n (total)
dilatation (%)
FU
Westling
1998
22 (77)
17
24
Forsell
1999
2 (326)
Niville
1999
Weiss
0.6
28
7 (9)
77.8
11
2000
12 (43)
27.9
6
DeMaria
2001
18 (25)
71
21
Peternac
2001
31 (68)
45.8
12
Weiss #
2002
5 (28)
27.7
23
10 (24)
71.4
24
Ceelen
2003
7 (625)
1.1
20*
Weiner
2003
24 (984)
2.4
56*
Chevallier
2004
5 (1000)
0.5
NA
Gutschow
2005
6 (20)
Fielding
2005
1 (34)
Dargent
2005
505 (1232)
41
NA
Klaus #
2006
18 (52)
34.6
33
20 (112)
17.9
33
17 (121)
14
12
Milone
2008
30 2.9
56* 67
FU = mean follow-up in months, * = median, n = number of patients NA = not available, # = groups created by author for study purposes
55
56
Wiesner et al.5 found a relation between esophageal dilatation, poor weight loss and preoperative insufficiency of the LES. Klaus et al reported that dilatation was related to poor esophageal motility17. However reports about the long-term effects of esophageal dilatation on esophageal motility are lacking and also the role of altered motility in the development of esophageal dilatation is unclear. Assessment of esophageal dilatation after emptying the band was reported in four studies1,4,17,21. In all these studies a decrease of the dilatation was observed, but details were not provided. The effect of emptying the band in our study was not followed for more than one hour and it is possible that further decrease of diameter would have occurred if we had waited longer before repeating the barium study. It is also possible that, in the long term, esophageal dilatation may further increase with the risk for decompensation of the esophagus like in achalasia. We only studied 45 out of 180 patients. This relatively small group of patients seems representative for the total group of patients, but it is possible we over- or underestimate the percentage of dilatation. Our method to quantify esophageal dilatation was similar to the method of DeMaria et al.1 but is not evidence based. More systematic studies with larger group of patients are needed to definitively answer the question whether esophageal dilatation is a real problem and which is the best way to quantify esophageal dilatation. In conclusion: There is evidence of the development of esophageal dilatation after laparoscopic adjustable gastric banding. Esophageal dilatation seems related to time after surgery and insufflation of the band. Dilatation is (partly) reversible after emptying the band. Long-term, perhaps even life-long follow-up is needed in order to assess if further widening and loss of function of the esophagus will take place. REFERENCES 1. DeMaria EJ, Sugarman HJ, Meador JG, Doty JM, Kellum LM, Wolfe L, Szucs RA, Turner MA (2001) High failure rate after laparoscopic adjustable silicone gastric banding for treatment of morbid obesity. Ann Surg 233:809-18 2. Peternac D, Hauser R, Weber M, Schob O (2001) The effects of laparoscopic adjustable gastric banding on the proximal pouch and the esophagus. Obes Surg 11:76-86 3. Niville E, Dams A. Late pouch dilatation after laparoscopic adjustable gastric and esophagogastric banding: Incidence, treatment and outcome (1999) Obes Surg 9:381-384 4. Weiss HG, Nehoda H, Labeck B, Peer-Kuehberger MD, Oberwalder M, Aigner F, Wetscher GJ (2002) Adjustable gastric and esophagogastric banding: a randomized trial. Obes Surg 12:573-8 5. Wiesner W, Hauser M, Schob O, Weber M, Hauser RS (2001) Pseudo-achalasia following laparoscopically placed adjustable gastric banding. Obes Surg 11:513-8 6. WeinerR, Blanco-Engert R, Weiner S, Matkowitz R, Schaefer L, Pomhoff I (2003) Outcome after laparoscopic adjustable gastric banding - 8 years experience. Obes Surg 13:427-434 7. Chevallier JM, Zinzindohoue F, Douard R, Blanche JP, Berta JL, Altman JJ, Cugnenc PH (2004) Complications after laparoscopic adjustable gastric banding for morbid obesity:experience with 1,000 patients over 7 years. Obes Surg 14:407-14 8. Fielding GA, Duncombe JE (2005) Clinical and radiological follow-up of laparoscopic adjustable gastric bands, 1998 and 2000: a comparison of two techniques. Obes Surg 15:634-40 9. Belachew M, Belva PH, Desaive C (2002) Long-term results of laparoscopic adjustabe gastric banding for the treatment of morbid obesity. Obes Surg 564-568 10. Dargent J (2005) Esophageal dilatation after laparoscopic adjustable gastric banding: definition and strategy. Obes Surg 15:843-848 11. DeMaria E (2003) Laparoscopic adjustable silicone gastric banding:complications. J Laparoendoscop Adv Surg Techn 13:271-277
12. Weiss HG, Nehoda H, Labeck B, Peer-Kühberger MD, Klingler P, Gadenstätter M, Aigner F, Wetscher GJ (2000). Treatment of morbid obesity with laparoscopic adjustable gastric banding affects esophageal motility. Am J Surg 180:479-82 13. Gustavsson S, Westling A (2002) Laparoscopic adjustable gastric banding: complications and side effects responsible for the poor long-term outcome. Semin Laparoscopic Surg 9:115-24 14. Weiss HG, Kirchmayr W, Klaus A, Bonatti H, Mühlmann G, Nehoda H, Himpens J, Aigner F (2004) Surgical revision after failure of laparoscopic adjustable gastric banding. Br J Surg 91:235-41 15. Forsell P, Hallerback B, Gilse H, Hellers G (1999) Complications following swedish adjustable gastric banding: a long term follow-up. Obes Surg 9:11-16 16. Gutschow CA, Collet P, Prenzel K, Holscher AH, Schneider PM (2005) Long-term results and gastroesophageal reflux in a series of laparoscopic adjustable gastric banding. J Gastrointest Surg 9:941-948 17. Klaus A, Gruber I, Wetscher G, Nehoda H,Aigner F, Peer R, Margreiter R, Weiss H (2006) Prevalent esophageal body motility disorders underlie aggravation of GERD symptoms in morbidly obese patients following adjustable gastric banding. Arch Surg 141:247-251 18. Ceelen W, Walder J, Cardon A, Van Renterghem K, Hesse U, El Malt M, Pattyn P (2003) Surgical treatment of severe obesity with a low-pressure adjustable gastric band: experimental data and clinical results in 625 patients. Ann Surg 237:10-16 19. Lew JI, Daud A, DiGorgi MF, Olivero-Rivera L, Davis DG, Bessler M (2006) Preoperative esophageal manometry and outcome of laparoscopic adjustable silicone gastric banding. Surg Endosc 20:1242-47 20. Milone L, Daud A, Durak E, Olovero-Rivero L, Schrope B, Inabnet WB, Davis D, Bessler M (2008) Esophageal dilatation after laparoscopic adjustable gastric banding. Surg Endosc 22:1482-86 21. Spivak H, Hewitt MF, Onn A, Halff EE (2005) Weight loss and improvement of obesity-related illness in 500 U.S. patients following laparoscopic adjustable gastric banding procedure. Am J Surg 189:27-32
57
Chapter 6 SUSTAINED WEIGHT LOSS 2 YEARS AFTER LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING FOR MORBID OBESITY
W.W. te Riele, J.R. de Jong*, J.M. Vogten, M.J. Wiezer, P.H.Th.J. Slee#, B. van Ramshorst
Departments of Surgery and Internal Medicine#, Sint Antonius Hospital Nieuwegein, the Netherlands Department of Pediatric Surgery*, Wilhelmina Children’s Hospital,Utrecht, the Netherlands
Ned Tijdschr Geneeskd 2007; 151:1130-5
60
ABSTRACT Objective: To analyse the results of the laparoscopic adjustable gastric banding (LAGB) procedure for morbid obesity. Design: Retrospective, descriptive. Methods: From November 1, 1995 to May 31, 2005, laparoscopic adjustable banding surgery was performed in St. Antonius Hospital, Nieuwegein, the Netherlands, in 411 patients. Inclusion criteria were BMI > or = 40 kg/m(2) or BMI > 35 kg/m(2) and severe comorbidity with > 3 attempts at weight loss in the past. Selection, inclusion and follow-up were performed in a specialised, multidisciplinary setting. Height, weight, and complications were prospectively recorded. In 1995-2000 the perigastric surgical procedure was used and in 2000-2005 the pars-flaccida method. Results: The study group consisted of 350 (85%) women and 61 (I5%) men with a median age of 38 years (range 17-60). Out of these 411 patients, the median weight was 133.4 kg, the median overweight, 69.6 kg and the median BMI 46.3 kg/m2. Two years after surgery, data was known for 267 patients where 206 (77%) had a weight loss > 30%, and 7 patients (3%) a weight gain. The median BMI difference was then -10.2 kg/m2 (range +4.7—26.4). The median loss of overweight was 46.3% (+10.00—97.8). The weight loss remained stable in the following years. The most commonly seen complications were fundus slippage (13%) and port-a-cath related complications (7%). These occurred more often in patients who had had the perigastric method surgery than in the parsflaccida surgical method. Conclusion: Three quarters of the patients with morbid obesity who received laparoscopic gastric banding surgery had achieved and sustained weight loss at 2 years following surgery. The pars-flaccida method resulted in fewer complications than the perigastric surgical method. INTRODUCTION Obesity is a increasing threat to public health. Approximately half of all Dutch people have overweight (defined as body mass index (BMI) 25 kg/m2). Severe overweight or obesity (BMI 30 kg/m2) has a prevalence of approximately 10% for men and 11% for women and shows a rising trend over time (National Compass Public Health 2005; www.rivm.nl)1. The prevalence of overweight children has doubled in recent decades to about 10%2. Obesity is associated with an increased mortality risk (relative risk (RR): 1.8 and 2.5 with a BMI of 35 and 40 kg/m2, respectively) and severe co-morbidity. This includes cardiovascular disease, diabetes mellitus type 2, dyslipidemia, symptomatic cholelithiasis, gastroesophageal reflux, sleep-apnoe syndrome, osteoarthritis and low backpain3-6. These co-morbidities may lead to a reduced quality of life3. The treatment of patients with morbid obesity (BMI 40 kg/m2) focuses primarily on reducing comorbidity. A weight reduction of 10% already results in a significant decrease in co-morbidity7, 8. Because of the limited results of conservative therapy, an increasing attention to bariatric surgery (i.e. the surgical treatment of patients with morbid obesity) has been reported9, 10. Bariatric surgery has been proven effective for decreasing body weight on long term, thereby reducing risk factors and co-morbidity with improving the quality of life11, 12. Patients with a BMI 40 kg / m2 or BMI 35 kg / m2 with serious co-morbidities, with 3 attempts to lose weight through dietary changes and drug therapy are eligible for bariatric surgery6.13. A frequently used procedure in laparoscopic bariatric surgery is the placement of a gastric band. The initial experience with this surgery was reported in 199114. A Dutch study of 30 patients with a short follow-up of 10 months was already published in 1994 in this journal15. In 1995 the laparoscopic gastric banding procedure was introduced in our hospital. We describe the results of 411 patients who underwent a laparoscopic gastric banding procedure in a period of 10 years.
METHODS Patients All patients in the St. Antonius Hospital in Nieuwegein, in the period from November 1995 till May 2005, who underwent a gastric band placement were included in the study. The patients were selected by a multidisciplinary team (internist, psychologist, dietician and surgeon) on the basis of international guidelines for surgical treatment of morbid obesity6. These patients fulfilled the inclusion criteria of a BMI 40 kg/m2 or BMI 35 kg/m2, serious co-morbidities and 3 prior attempts to weight reduction through dietary changes and drug therapy. The main exclusion criteria were portal hypertension and severe psychiatric co-morbidity.
61 Figure 1. Silicone gastric band which is placed near the the gastroesophageal junction. The inside of the band consists of a balloon, which is connected to a tube and a subcutaneously located port-a-cath system. By filling or emptying the balloon, the nurse-practitioner adjust the diameter of the balloon in the outpatient clinic.
Surgery The silicone gastric band is placed laparoscopically near the the gastroesophageal junction. Because the band is on the inside equipped with a balloon, which is connected to a tube and a subcutaneous located port-a-cath system, it is possible to adjust the band diameter by filling or emptying the balloon.(Figure 1). During the study period two different gastric bands with similar mechanism of action were used16.The first 210 banding procedures were carried out by the perigastric technique, the last 201 according to the pars-flaccida technique17. All interventions were performed by one surgeon (BvR). Follow-up and data collection Body weight data and complications were recorded in a prospective database. Postoperatively, during the first year, all patients were seen every 3 months in the outpatient clinic. Thereafter they were monitored every 6 months. Outcome Measures The percentage of successfully treated patients was calculated based on the number of patients with a postoperative follow-up 2 years. Successful obesity treatment was defined as a excess weight loss > 30%. We also looked at complications that occurred < and 30 days after surgery.
Statistical analysis The overweight and weight loss were calculated using the ideal body weight according to the length-weight tables of the Metropolitan Life Insurance Company18. Statistical differences between pre-and postoperative weight were calculated using the Mann-Whitney U test. The group of patients was further divided for subgroup-analysis using the baseline BMI (categories: 35-39.9, 40-44.9, 50-54.9, and 55 kg/m2).
RESULTS Study Population In the study period a laparoscopic gastric banding procedure was carried out in 411 patients. The patient characteristics are listed in Table 1. The median stay in hospital of the patients was 2 days (range: 1-10).
Table 1. Preoperative data of 411 patients in whom a laparoscopic gastric band was placed, St. Antonius Hospital, Nieuwegein, 1995 /’05 number of women (%) median age in years (range) median weight in kg (range)
350 (85) 38 (17-60) 133.4 (88.4-230.0)
62 median excess weight in kg (range)
69.6 (32.1-113.4)
median BMI in kg/m2 (range)
46.3 (36.2-84.3)
number of patients with BMI in kg/m2 (%) 35-39.9
39 (9)
40-44.9
156 (38)
45-49.9
112 (27)
50-54.9
57 (14)
> 55
47 (11)
Follow-up Fifty-two of the 411 patients (13%) did not complete follow-up: in the period 1995-1999 41/210 patients (20%) were lost from follow-up, in the period 2000-2005 8/201 patients (4 %). Three patients died due to a non-surgery related cause (2 with a malignancy and 1 by suicide). The median follow-up time of the other 359 patients was 39 months (range 3-108). There were 267 patients with a follow-up time 2 years. Out of this group, 26 patients (10%) were lost from follow-up.
Figure 2. Excess weight loss in 260 of the 267 patients who underwent a gastric banding procedure 2 years before. In 7 patients (3%) the weight increased (not shown)
Number (%) of patients
excess weight loss (%)
7(3)
0-9.9
14 (5)
10-19.9
33 (12)
20-29.9
37 (14)
30-39.9
54 (20)
40-49.9
55 (21)
50-59.9
30 (11)
60-69.9
16 (6)
70-79.9
8 (3)
80-89.9
6 (2)
90-100
% of patients
63
Excess weight loss Of the 267 patients with follow-up data of 2 years in 206 (77%) a decrease in overweight 30% was found (Figure 2). In 7 (3%) patients the weight increased. The median BMI reduction 2 years after laparoscopic gastric banding BMI was 10.2 points (Table 2). The median excess weight loss was 46.3% (see Table 2). The decrease was almost stable during the following years (Figure 3). In the subgroups with a lower preoperative BMI, the percentage excess weight loss after gastric banding was higher than in the groups with a higher baseline value of BMI (see Table 2). Complications In 19 of the 411 patients (5%) a conversion to an open procedure was performed due to a hypertrophic liver lobe, bleeding or complex anatomy. Early complications were wound infections, gastric perforation and laceration of the liver (Table 3). Late complications were herniation of the fundus through the band, problems related to the porta-cathsystem (leakage, infection and dislocation) and gastric erosion. Fundus herniation was seen more often after the perigastric than after the pars flaccida technique (see Table 3). The complications did not affect the final weight loss (data not shown). No thromboembolic complications were found during follow-up. The surgically related mortality rate was zero. In 90 of the 411 patients (22%) a reoperation was carried out ( fundus herniation (n = 55), revision of the port-a-cath system (n = 30) and removal of the gastric band (n = 5).
Table 2. Decrease of overweight in 267 patients, 2 years after laparoscopic gastric banding 1995-2005, St. Antonius Hospital, Nieuwegein Total (n = 267)
Women (n = 228)
Men (n = 39)
Median BMI (kg/m2)
44.9
44.5
46.4
Range
36.1-69.1
36.1-69.1
36.2-60.1
Preoperative
Median difference between pre- and postoperative BMI (kg/m2) Range
-10.2 +4.7- -26.4*
-10.3 +4.7- -26.4
-9.8 -1.5- -22.2
Excess weight loss (%)
-46.3
-45.4
-46.2
Range
+10.0- -97.8
+10- -97.8
-9.4—80.4
Preoperative 64 Subgroup classified according to BMI
35-39.9
40-44.9
45-49.9
50-54.9
> 55
Number of patients (n)
25
102
70
38
32
Median BMI (kg/m2)
38.7
42.2
47.1
51.1
58.6
Range
36.1-39.9
40.0-44.8
45.0-49.7
50.1-54.9
55.3-69.1
11.1
13.6
14.3
43
45
38
Median difference between pre- and postoperative BMI (kg/m2) Excess weight loss (%)
8.9 54
9.3 46
DISCUSSION In contrast to our neighboring countries, in our country there is only little experience in the surgical treatment of obesity. Our report includes the first long-term results of laparoscopic gastric banding in the Netherlands and shows a statistically significant and sustainable reduction of 30% overweight in 77% of the patients with a follow-up duration 2 years. The reported median BMI decrease of 10.2 points and the median excess weight loss of 46.3% correspond with the results reported in the literature11,19-21. Buchwald et al. found in a meta-analysis, a mean decrease in BMI of 10.4 points and an excess weight loss of 47.5%22.
excess weight loss (%)
median BMI (kg/m2)
Figure 3. Course of weight loss for 411 patients after laparoscopic gastric banding expressed as (a) BMI and (b) percentage of overweight lost. In 7 of the 267 patients (3%), the weight increased. N = number of patients involved
The advantages of the laparoscopic placement of the gastric band are the minimally invasive character of surgery and the rapid clinical recovery. A randomized study in our department already showed that surgery is safe and cost effective and is possible as day care surgery23. Other advantages are the possibility of calibration of the band with a controlled food intake and finally, the reversibility of the operation. If there is insufficient effect of the band or insufficient adherence of the patient, the band can be removed leaving the integrity of the gastrointestinal tract undisturbed. After switching to the pars flaccida technique by placing the band just below the gastrooesophageal junction the rate of herniation decreased significantl24. Other complications were mainly related to the port-a-cath reservoir and were treated in the outpatient clinic or day care surgery. The complications did not affect the final weight loss. In the literature, long-term results are often expressed as patients in follow-up.
65
Table 3. Number (%) of patients with a complication after laparoscopic adjustable gastric banding, St. Antonius Hospital, Nieuwegein, 1995-2005 Perigastric method 1995-2000 (n = 210)
Pars flaccida method 2000-2005 (n = 201)
Total 1995-2005 (n = 411)*
Wound infection
3
3
6 (1.5
Gastric perforation
2
1
3 (0.7)
Liver laceration
1
0
1 (0.2
Herniation of the fundus†
50
5
55 (13)
Port-a-cath problems‡
18
12
30 (7)
Gastric erosion
1
0
1 (0.2)
< 30 days postoperative
> 30 days postoperative
66
* of 52 of the 411 patients incomplete follow-up data were available. In the remaining 359 patients, the median follow-up time was 39 months (range: 3-108). † The median time to occurrence of a fundus herniation was 20 months (range: 1-87). ‡ The median time to occurrence of a port-a-cath problem was 25 months (range: 4-82).
Shen et al. showed a clear relationhip between an adequate follow-up and weight loss in patients after laparoscopic gastric banding25. During the follow-up we lost 13% of the patients, the majority in the early period of the study. After the appointment of a nurse-practitioner, this loss was minimized and a follow-up percentage of 96 was achieved. Usually, a decrease in body weight > 30% is considered as a measure of successful obesity treatment26. The maximum weight loss in the majority of patients from has been achieved 1.5 to 2 years postoperatively. In our study 77% of the patients with a follow-up time 2 years showed an excess weight loss 30% (see Figure 2). If we consider the patients lost after 2 years as failures (n = 26 of 206), the success rate decreased to 67% (180/267). The success of the surgical treatment of morbid obesity should not only be measured in terms of weight loss, but also expressed in decrease of co-morbidity and increase in quality of life. In previous studies, we already reported a statistically significant improvement in the quality of life after laparoscopic gastric banding12,27. The effect of surgery on the co-morbidities in this group have not been analyzed till now. However, it is known from the literature that a weight loss of 10% is already associated with a significant reduction of comorbidity7,8. Buchwald et al. showed in a meta-analysis a significant decrease of diabetes mellitus, hyperlipidemia, hypertension and sleep apnoe syndrome after bariatric surgery22. In the analysis of the subgroups, classified according to BMI at the start of the study, we found a greater effect of treatment for patients with lower baseline BMI (excess weight loss 54%) com-
pared to patients with a higher value (excess weight loss 38% ). The indication for bariatric surgery in patients with a BMI 50 is still the subject of discussion28. In contrast with the practice in Europe and Australia, the preferred surgical procedure in the United States is the laparoscopic gastric bypass procedure. This operation results in a greater weight loss within a shorter time and gives a higher percentage of successfully treated patients than the gastric banding procedure. However, the price is a significantly increased morbidity and mortality29. Randomized comparative studies of the results of the gastric bypass procedure and laparoscopic gastric banding are lacking so far, but would respond to the question which operation is the best for patients with (severe) morbid obesity. CONCLUSION Three quarters of the patients with morbid obesity who received laparoscopic gastric banding surgery had achieved and sustained weight loss at 2 years following surgery. The pars-flaccida method resulted in fewer complications than the perigastric surgical method. REFERENCES 1. Visscher TL, Kromhout D, Seidell JC. Long-term and recent time trends in the prevalence of obesity among dutch men and women. Int J Obes Relat Metab Disord. 2002; 26:1218-24. 2. Hirasing RA, Fredriks AM, Buuren S van, Verloove-Vanhorick SP, Wit JM. Toegenomen prevalentie van overgewicht en obesitas bij Nederlandse kinderen en signalering daarvan aan de hand van internationale normen en nieuwe referentiediagrammen. Ned Tijdschr Geneesk 2001; 145:1303-8. 3. Fauci AS, Braunwald E, Isselbacher KJ, Wilson JD, Martin JB, et al. Harrison’s Principles of internal medicine. 14e editie. McGraw Hill. New York 1998. pp 454-62. 4. Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003; 348:1625-38. 5. Mokdad AH, Ford ES, Bowman BA, Dietz WH, Vinicor F, Bales VS, et al. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA 2003; 289:76-9. 6. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults— the evidence report. National Institutes of Health. Obes Res 1998; 6 Suppl 2:51S-209S. 7. Lean ME, Powrie JK, Anderson AS, Garthwaite PH. Obesity, weight loss and prognosis in type 2 diabetes. Diabet Med 1990; 7:228-33. 8. Lavie CJ, Milani RV. Effects of cardiac rehabilitation, exercise training, and weight reduction on exercise capacity, coronary risk factors, behavioral characteristics, and quality of life in obese coronary patients. Am J Cardiol. 1997; 79(4):397-401. 9. Goodrick GK, Foreyt JP. Why treatments for obesity don’t last. J Am Diet Assoc. 1991; 91(10):1243-7. 10. Maggard MA, Shugarman LR, Suttorp M, Maglione M, Sugarman HJ, Livingston EH, et al. Meta-analysis: surgical treatment of obesity. Ann Intern Med.2005; 142(7):547-59. 11. Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, et al.Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004; 351(26):2683-93. 12. Larsen JK, Geenen R, Ramshorst B van, Brand N, Wit P de, Stroebe W, et al. Psychosocial functioning before and after laparoscopic adjustable gastric banding: a cross-sectional study. Obes Surg 2003; 13(4):629-36. 13. Zelissen PM, Mathus-Vliegen EM. Behandeling van overgewicht en obesitas bij volwassenen: voorstel voor een richtlijn. Ned Tijdschr Geneesk 2004; 148(42):2060-6. 14. Kuzmak LI. A review of seven years’ experience with silicone gastric banding. Obes Surg 1991; 1(4):403-8. 15. Eerten PV van, Tuinebreijer WE, Breederveld RS, Kreis RW, Hunfeld MA, Groot GH de. Bariatrische chirurgie met een variabele maagband voor morbide obesitas: eerste 30 patiënten in Nederland. Ned Tijdschr Geneeskd 1994; 138(15):762-6. 16. Fried M, Miller K, Kormanova K. Literature review of comparative studies of complications with swedish band and lap-band. Obes Surg 2004; 14(2):256-60.
67
17. Belachew M, Zimmermann JM. Evolution of a paradigm for laparoscopic adjustable gastric banding. Am J Surg 2002; 184(6B):21S-5S. 18. Robinett-Weiss N, Hixson ML, Keir B, Sieberg J. The Metropolitan height-weight tables: perspectives for use. J Am Diet Assoc 1984; 84(12):1480-1. 19. Ceelen W, Walder J, Cardon A, Renterghem K van, Hesse U, El Malt M, et al. Surgical treatment of severe obesity with a low-pressure adjustable gastric band: experimental data and clinical results in 625 patients. Ann Surg 2003; 237(1):10-6. 20. Zinzindohoue F, Chevallier JM, Douard R, Elian N, Ferraz JM, Blanche JP, et al. Laparoscopic gastric banding: a minimally invasive surgical treatment for morbid obesity: prospective study of 500 consecutive patients. Ann Surg 2003; 237(1):1-9. 21. Angrisani L, Di Lorenzo N, Favretti F, Furbetta F, Iuppa A, Doldi SB, et al. The Italian Group for LAP-BAND: predictive value of initial body mass index for weight loss after 5 years of follow-up. Surg Endosc 2004; 18(10):1524-7. 22. Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach L et al. Bariatric surgery. A systematic review and meta-analysis. JAMA 2004; 292(14):1724-37. 23. Wasowicz DK, Bliemer B, Boom FA, de Zwaan NM, Ramshorst B van. Laparoscopic Adjustable Gastric Banding: outpatient procedure versus overnight stay, a randomized study. Obes Surg. 2003; 13:ASBA Abstracts P47. 24. O’Brien PE, Dixon JB, Laurie C, Anderson M. A Prospective Randomized Trial of Placement of the Laparoscopic Adjustable Gastric Band: Comparison of the Perigastric and Pars Flaccida Pathways. Obes Surg 2005; 15(6):820-6. 25. Shen R, Dugay G, Rajaram K, Cabrera I, Siegel N, Ren CJ. Impact of patient follow-up on weight loss after bariatric surgery. Obes Surg 2004; 14:514-19. 26. Favretti F, Cadiere GB, Segato G, Busetto L, Loffredo A, Vertruyen M, et al. Bariatric analysis and reporting outcome system (BAROS) applied to laparoscopic gastric banding patients. Obes Surg 1998; 8(5):500-4. 27. Schok M, Geenen R, Antwerpen T van, de Wit P, Brand N, Ramshorst B van. Quality of life after laparoscopic adjustable gastric banding for severe obesity; postoperative and retrospective preoperative evaluations. Obes Surg 2000; 10:502-08. 28. Parikh MS, Shen R, Weiner M, Siegel N, Ren CJ. Laparoscopic Bariatric Surgery in Super-Obese Patients (BMI > 50) Is Safe and Effective: a Review of 332 Patients. Obes Surg 2005; 15(6):858-63. 29. Angrisani L, Lorenzo M, Borrelli V. Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 5-year results of a prospective randomized trial. Surg Obes Relat Dis. 2007; 2 :127-32.
Chapter 7 EFFECTS OF ADJUSTABLE GASTRIC BANDING ON GASTROESOPHAGEAL REFLUX AND ESOPHAGEAL MOTILITY. A SYSTEMATIC REVIEW
J.R .de Jong1, M.G.H. Besselink2,3, B van Ramshorst2, H.G.Gooszen3, A.J.P.M. Smout4
1. Dept. of Pediatric Surgery, Academic Medical Center, Amsterdam 2. Dept. of Surgery, St Antonius Hospital, Nieuwegein 3. Dept. of Surgery, University Medical Center, Utrecht 4. Dept. of Gastroenterology, University Medical Center, Utrecht
Submitted
70
ABSTRACT Background: Controversial opinions exists concerning the effect of laparoscopic adjustable gastric banding on gastroesophageal reflux. We aimed to review the effect of gastric banding on gastroesophageal reflux and esophageal motility. Methods: MEDLINE and EMBASE databases were searched for relevant studies on patients undergoing adjustable gastric banding. Outcome measures were: reflux symptoms, medication use, esophagitis, pathological reflux measured by pH recording, LES (lower esophageal sphincter) function and esophageal peristalsis. Data are expressed as: mean (range). Results: Seventeen studies were identified with a total of 1839 patients. The prevalence of reflux symptoms decreased postoperatively from 32.2% (16-48.4) to 9.1% (0-26.9) and medication use from 27.5% ( 16-38.5) to 9.5% (3.1-19.2). Newly developed reflux symptoms were found in 15% (6.1-20) of the patients. The percentage of esophagitis decreased postoperatively from 33.3% (19.4-61.6) to 27% (2.3-60.8). Newly developed esophagitis was observed in 22.9% (0-38.4). Pathological reflux was found in 55.8% (34.9-77.4) preoperatively and postoperatively in 29.4% (0-41.7) of the patients. LES pressures increased from 12.9 mmHg (6-22) to 16.9 mmHg (11.3-21.4). LES relaxation decreased from 100% to 79.7% (58-86). The percentage of dysmotility increased from 3.5% (0-10) to12.6% (0-25). Conclusion: Adjustable gastric banding has anti-reflux properties resulting in resolution or improvement of reflux symptoms, normalized pH monitoring results and a decrease of esophagitis. However, worsening or newly developed reflux symptoms and esophagitis are found in a subset of patients during longer follow-up. Pouch dilatation, filling of the band and disordered esophageal motility are possible causative factors. Adjustable gastric banding increases LES pressure, but decreases LES relaxation and is associated with an increase in disturbed esophageal peristalsis. INTRODUCTION Obesity is considered an important risk factor for gastroesophageal reflux and esophagitis (1-4). There are also studies however, in which no relation between obesity and reflux was found (5,6). Although it is reasonable to assume that weight loss will result in decrease of reflux and weight reduction is often recommended as a first line conservative treatment, there is a lack of literature supporting this recommendation (7). Even an increase of reflux after weight loss has been reported (8). During the last decades several operations have been developed to treat morbid obesity with good long-term weight loss (9). The surgical procedures can be divided into (a) restrictive procedures in which the stomach is partitioned by staple lines, mesh or band, (b) procedures that induce malabsorption and (c) procedures in which combinations of the aforementioned techniques are used. In the classical restrictive procedures (non-adjustable gastric banding, vertical banded gastroplasty, horizontal gastroplasty) the stomal size between the partitioned stomach could not be adjusted after the completion of the procedure. The most popular restrictive procedure nowadays is the adjustable silicone gastric banding in which the stomal size can be modified postoperatively. It is well known from the past that the classical restrictive procedures led to an increase in reflux symptoms and esophagitis which led to abolition of these procedures in many centers for obesity surgery (10-14). This may be caused by the fact that in all cases a proximal gastric pouch is created with a relatively narrow stoma which is likely to lead to increased resistance to flow and to increased gastroesophageal reflux. Controversial opinions exist about the effect of adjustable gastric banding on gastroesophageal reflux and esophageal motility (15-20). We aimed to review all published reports about the effects of adjustable gastric banding on gastroeesophageal reflux and esophageal motility.
1998 1999 2000 2000 2001 2002 2002 2004 2004 2005 2005 2005 2005 2006 2006 2006 2006
Niville41 § Dixon23 Anderson34 Weiss15 Weiss29 Weiss27 § Korenkov35 De Jong19 Frigg38 Suter17 Spivak38 Ahroni43 Gutschow16 Klaus28 Lew37 § Tolonen20 De Jong18
Belgium Australia Australia Austria Austria Austria Germany Netherlands Switzerland Switzerland USA USA Germany Austria USA Finland Netherlands
Country
1994-1997 1996-1998 NR 1998-1999 1998-1999 1998-1998 1997-2000 1998-2000 1996-2002 1999-2002 2000-2003 2002-2003 1997-2003 1996-2002 2001-2003 2003-2004 1998-2000
Inclusion 93 45 NR 36 40 24 24 23 233 37 NR 161 27 499 58 26 26
F
34 4 88 19 5 3
7 7 4 6 3 62 6
33 3
M 37 (NR)† 39 (23-58)* NR 39 (19-63)* 36 (32-43.5)¥ 40 (18-62) 38 (25-54)* 41.3 (6.4)† 41(18-67)‡ 39 (25-59)‡ 42 (18-63)‡ 43.8 (19-70)‡ 37 (20-61)‡ 39 (8.8)† 45 (8.3)† 44 (11)† 41.3 (6.4)†
Age
BMI postop NR NR NR 33.1 (29.4-37.3)* 33.5(29.6-37.2)¥ 25.1 (22.4-36.3)* NR 36.7 (1.0)# 35 (22-52)‡ 33.8 (NR) 35.1 (NR) 32.3 (7.0)† 35 (7.8)† 28.2 (5.1)† NR 38.4 (6.5)† 36.7 (4.4)†
BMI preop 42.3 (NR)† 45 (7)† NR 42.5 (39.3-47.3)* 43.5 (40.8-47.5)¥ 42.5 (39.3-47.3)* 46.4 (5.4)$ 47 (1.2)# 45 (31-75)‡ 42.2 (34.4-53.2)‡ 45.2 (35-61)‡ 45.8 (7.7)† 46.5 (38.3-59.8)‡ 46.7 (9.8)† 47.9 (4.5)† 46 (5.5)† 46.1 (4.8)†
NR 24 24 6 9 24 22 6 44 10 20 12 59,3 33 12 19 6
FU 126 48 60 43 47 52 32 26 295 43 163 149 31 587 77 31 29
N
NR = not reported; N = number of patients; FU = follow-up time in months, ST = surgical technique:PF = pars flaccida,PG = perigastric, EG = esophagogastric Values are median (range)*, mean (SD)†, mean (range)‡, mean (SEM)#, median (SD)$, median (interquartile range)¥ 1 = reflux symptoms, 2 = medication use, 3 = esophagitis, 4 = pH monitoring, 5 = manometry § = authors created two groups, mean results of both groups are given
Year
Reference
Sex ratio
Table 1 Demography of patients in included studies with indication of relevance for the different subjects of the review.
71
PG EG PG PG PG PF PF EG PG PG PG PF PG PF PG PF PF PG PF PF PF PG
ST
1 1,2 3 1,3,4,5 1,5 1 1,5 1,2,3,4 1 1,3,4,5 1,2 1,2 1 1 1 1,2,3,4,5 5
Relevance
METHODS The MEDLINE and EMBASE databases were searched for studies published since 1990 until December 31, 2006. The following keywords and combinations were used: gastric banding, reflux, gastroesophageal reflux, reflux symptoms, motility, esophagitis, endoscopy, manometry, pH monitoring. Also the abstracts of major meetings concerning surgical treatment of morbid obesity, ASBS (American Society for Bariatric Surgery), IFSO (International Federation for the Surgery of Obesity) and Australia and New Zealand Society of Obesity Surgeons, were screened. Reference lists of all selected articles that included information about adjustable gastric banding and reflux were reviewed for other relevant articles. Studies were excluded when they involved non-adults, were written in another language than English or concerned animal experiments. The following selection criteria were used for inclusion in this study: (a) study design: prospective, (b) reflux symptoms: only studies with pre- and postoperative reports of reflux symptoms (heartburn and regurgitation), (c) medication use: studies with pre- and postoperative results, (d) pH recordings: studies with pre- and postoperative recordings with the results reported as total reflux time or DeMeester score, (e) manometry: studies with pre- and postoperative recordings, (e) esophagitis: studies with pre-and postoperative esophagogastroduodenoscopy reporting the grade of esophagitis. Only studies in which postoperative results were reported in more than 75% of the patients were included. Articles were retrieved and reviewed by two authors (JRdJ and BvR). All differences were discussed among the reviewers. Characteristics of studies involved in the systematic review are given in Table 1.
72
Our study questions were: 1) Does adjustable gastric banding diminish reflux symptoms and decrease use of antacid medication? 2) Is there a decrease in pathological reflux measured by pH monitoring after adjustable gastric banding? 3) Does adjustable gastric banding decrease esophagitis? 4) Is there a change in esophageal motility after adjustable gastric banding?
RESULTS Reflux symptoms and use of medication Of 21 detected studies, five studies were excluded because of retrospective data collection (21), restriction to patients who had a crural repair (22), reporting on the same group of patients twice (23,24), impossibility to retrieve percentages by use of a cumulative scoring system (25) or identification of patients with reflux disease on the basis of use of proton pump inhibitors (26). Fifteen studies were available for the assessment of reflux symptoms. Eleven of these studies, reported reflux symptoms in general. Three studies discriminated between heartburn and regurgitation (16,19,27). Only five studies analyzed the use of medication (Table 2). As shown in Table 2 the preoperative incidence of reflux symptoms varied from 16% to 57%. A decrease in reflux symptoms and use of antacids after adjustable gastric banding was found in all studies. Only one study reported an increase in heartburn (16). However an increase in regurgitation after gastric banding was found in three studies with a mean follow-up of 29 months (range 6-59.3 ) (15,16,19). Newly developed reflux symptoms after gastric banding in patients without prior symptoms were found in 6 to 50 % of patients (Table 3).
Table 2. The effect of adjustable gastric banding on reflux symptoms and the use of medication
Reference
N
Reflux symptoms preop postop
Heartburn preop postop
Regurgitation preop postop
Medication preop postop
Niville
40
25
10
NR
86
31.4
0
NR
Dixon
274
16
4.4
Weiss
43
27.9
2.3
6
Weiss
47
29.8
8.5
9
Weiss
28
33.1
11.1
27.7
0
23
24
42.9
14.3
21.4
35.7
24
16
3.1
FU
24
Korenkov
30
18.8
9.3
De Jong
26
42.3
26.9
Frigg
295
57
11.4
Spivak
163
29.4
3.6
Ahroni
149
50.3
Suter
43
28.8
Gutschow
31
Klaus
587
27.9
8.9
33
Lew
77
29
14.3
12
39
8
12
48.4
6.1
Tolonen
31
22 42.3
23.1
7.7
53.8
38.5
19.2
6 44
29.4
3.6
20
18.1
8.7
12
17.7
10 19.4
33.3
0
33.3
N = number of patients; NR = not reported; FU = follow up in months Reflux symtoms, heartburn, regurgitation and medication: % of patients
59
35.5
12.9
19
73
Table 3. Evolution of reflux symptoms (%) following laparoscopic adjustable gastric banding.
Reference
resolution
Ahroni Lew
improvement
worsening
81.3
10.6
newly developed
92 100
Frigg
79
11
6.1
Suter
84.6
18.7
Gutschow
84
13.9* 50 #
De Jong
72.7
20 * 46 #
Klaus 74
68.3
Korenkov
31.7 10
Spivak
72.9
Tolonen
86.6
7
12.5
14.6 18.8
* = heartburn, # = regurgitation
pH monitoring Of 9 studies, 4 were excluded because: follow-up studies were only performed in a subset of the preoperative population (25,27), follow-up was reported in < 75 % of the patients (16,25) or because postoperative reflux parameters were missing (28). Four studies in which pH monitoring was performed before and after adjustable gastric banding were included (Table 5). One author published two studies that fulfilled the inclusion criteria but (15,29) only the study with special interest in gastroesophageal reflux was included (15). The interval between the pre- and post-operative pH recordings varied from 6 to 19 months. A decrease in the percentage of patients with pathological reflux was found in all studies. However the mean total reflux time (especially reflux in supine position) increased in two studies (17,19). In these studies there were several patients with severe reflux postoperatively who contributed to the increase in mean time. Two studies reported the development of pathological reflux in 14.3% (20) and 30.1% (19) of patients postoperatively who did not have pathological reflux preoperatively.
Table 4. Effect of adjustable gastric banding on esophagitis as detected by endoscopy
Reference Year
Anderson 2000
Weiss 2000
De Jong 2004
Suter 2005
Tolonen 2006
preop
60
43
26
43
31
postop
60
43
23
36
25
Esophagitis (%)
preop
40
23.3
61.6
22.2
19.4
Grade
1
32
23.3*
38.5
22.2*
19.4*
2
4
3
0
0
0
0
0
4
0
0
0
0
0
5
4
0
0
0
0
Esophagitis (%)
postop
28
2.3
60.8
36.1
8
Grade (%)
1
24
2.3*
34.8
36.1*
8*
2
4
3
0
0
4.3
0
0
4
0
0
0
0
0
5
0
0
0
0
0
Follow-up (months)
24
6
6
9.6
19
Alterations in esophagitis (%) resolved
NR
90
37.5
62.5
NR
unchanged
NR
10
50
37.5
NR
worsened
NR
0
12.5
0
NR
newly developed
NR
0
30.4
38.4
NR
Number of patients
23.1
75
21.7
NR = not reported, * = reported grade 1 and 2 together
Esophagitis Of 14 potentially relevant studies nine studies were excluded because of having less than 75% followup endoscopy (16,27,30), examining only pre- or postoperative patients (29,31-33), giving no percentages of esophagitis (28) or excluding patients without postoperative endoscopy (27). Five studies were included (Table 4 ), four of which were full text articles (15,17,19,20)) and one abstract (34).
Table 5. The influence of adjustable gastric banding on reflux measured by pH recording
Reference Number of patients
Weiss
Suter
de Jong
Tolonen
preop
43
43
26
31
postop
43
36
26
24
preop
10.7 (5.3-15)‡
17.04
38.5 (24.9)†
postop
2.9 (0.9-5.6)‡
18.47
18.6 (20.4)†
preop
34.9
61
50
77.4
postop
0
41.7
38.4
37.5
preop
4.58$
5.2 (0.7)*
9.5 (6.2)†
postop
4.84$
7.1 (1.7)*
3.5 (3.7)†
preop
2.07$
2.3 (0.8)*
postop
5.03$
7.5 (2.4)*
preop
6.16$
6.9 (0.8)*
postop
4.47$
6.5 (1.5)*
preop
74.6$
38.6 (4.0)*
44.6 (23.7)†
postop
53.1$
39 (9.8)*
22.9 (17.1)†
9.6
6
19
De Meester score
% pathologic reflux
% total time pH < 4
76
Supine reflux %
Upright reflux %
Reflux episodes
Follow up (months)
6
Values are: mean (SEM) *, mean (SD)†, median (range)‡, mean$
Preoperatively, esophagitis was found in up to 60 % of patients, mainly grade 1 and 2 according to Savary Miller. (Table 4 ) A decrease in esophagitis after adjustable gastric banding varying from 4.6 to 21 percent was found in four studies. Only Suter et al. found an increase of esophagitis in 13.9% of their patients during 9.6 month follow-up (17). No single study demonstrated a statistically significant increase in the grade of esophagitis after adjustable gastric banding. Three studies reported the alterations in esophagitis per patient (15,17,19). Adjustable gastric banding resulted in healing of the esophagitis in 37.5 to 90 % of patients. New onset esophagitis in patients without esophagitis preoperatively was observed at follow-up endoscopy in up to 38.4% (range 30.4-38.4) of the patients after adjustable gastric banding. Esophageal motility Of 10 studies identified, 4 were excluded because of incomplete follow-up (25,29), not providing data on manometry (16), or only measuring a subset of patients with reflux symptoms (28). Six studies were appropriate for analysing results of esophageal manometry preoperatively and postoperatively (Table 6). As shown in table 6, impaired esophageal peristalsis after band placement was found by four authors (15,17,20,27). One study could not confirm a negative influence of adjustable gastric banding on esophageal motility (18). All but one studies found an increase of the LES pressure after adjustable gastric banding. In most studies, gastric banding was found to lead to decreased LES relaxation. In two studies the length of the LES ( or high pressure zone length) was increased by the procedure (18,35). DISCUSSION This review demonstrates mainly positive effects of adjustable gastric banding on gastroesophageal reflux resulting in a decrease in reflux symptoms, reduced use of antacid medication, a decreased prevalence of esophagitis and a lower percentage of patients with pathological reflux. The antireflux effect of the band is likely to be caused by an augmentation of the LES by creating a longer intraabdominal pressure zone or by pulling the the stomach more in the abdomen in the presence of a hiatal hernia (19).These mechanisms are similar to those previously reported following placement of the Angelchick prosthesis for gastroesophageal reflux disease (36) REFLUX SYMPTOMS The positive influence of band placement on reflux symptoms was reported to occur immediately after the operation or within 6 weeks , prior to any major weight loss, suggesting an effect of the band itself (19,23,37,38). Beside the positive effect of adjustable gastric banding, worsened or newly developed reflux symptoms in patients were reported postoperatively (16,17,19,20,28,35, 39). It has been proposed that longer follow-up time after operation with progressive filling of the gastric band and pouch dilatation are responsible for the development of new or worsened reflux symptoms (16,17,19). Some authors suggested a relation between postoperative reflux symptoms and pouch dilatation (19,38,40). More evidence for the role of pouch size and reflux symptoms was reported by Niville and co-workers who compared esophagogastric band placement (i.e. around the distal esophagus, leaving almost no pouch) and conventional adjustable gastric banding (41). In that study a complete resolution of gastroesophageal reflux symptoms following esophagogastric banding was found and the decrease of reflux symptoms was smaller in the group of patients with the conventional gastric banding procedure (larger pouch).
77
0 (0-20)† 20 (7.5-43)†
100 (100-100)† 86 (65-100)†
NR NR
Dysmotility (%) preop postop
LES relaxation (%) preop postop
LES length (cm) preop postop 8,9
NR NR
100 (100-100) 75 (52-77)
0 (0-10)† 25 (12.5-37.5)
NR = not reported Values are : mean(SD)*, mean (SEM)‡, median (interquartile range)†
6
10.9 (8-15.6)† 21 (11-26)†
LES pressure (mmHg) preop postop
Follow-up (months)
47 47
43 43
10.7 (7.8-13.5)† 18 (14.9-27.5)†
Weiss
Weiss
Reference Number of patients preop postop
22
3.9 (0.7)* 4.2 (0.5)*
100 (0)* 100 (0)*
NR NR
12.1 (4.8)* 13.3 (4.8)*
30 30
Korenkov
9,6
NR NR
NR NR
4,6 10,2
16.2 (0.9)‡ 16.7 (1.8)‡
43 40
Suter
6
5.0 (4.3-6.0)† 6.0 (5.5-6.4)†
100 (100-100)† 58 (48.6-75.4)†
10 (0-10)† 0 (0-20)†
6 (4.5-9.4)† 11.3 (9.8-14.3)†
29 29
De Jong
Table 6. Influence of laparoscopic adjustable gastric banding in the lower esophageal sphincter and esophageal motility
78 19
NR NR
NR NR
3,2 8
22.0 (9.1)* 21.4 (9.2)*
31 25
Tolonen
An increase in regurgitation was found by several authors during follow-up (16,19,27). Weiss and coworkers observed an increase in regurgitation in the group of patients treated by esophagogastric band placement which resulted in stasis of food in the esophagus (27). De Jong and Gutschow described the progressive filling of the band with stasis in the pouch and /or esophagus as a factor that promotes regurgitation (16,19). Apart from the role of the pouch and the filling grade of the band, it is unclear why in some patients reflux symptoms develop during follow-up whereas in others they do not. pH monitoring The studies in which pH recording was carried out showed a clear decrease in patients with a pathological reflux. It appears that the likelihood of increased esophageal acid exposure increases with increasing intervals after adjustable gastric banding. De Jong and coworkers found a decrease in reflux time at 6 weeks postoperatively, before filling of the band, but an increase at 6 months (19). Weiss and co-workers initially described normal esophageal acid exposure in all patients postoperatively but in later studies carried out by this group an increase in reflux was found after a follow- up of 33 months (15,28). This worsening was associated with poor esophageal motility preoperatively. The increase in supine reflux reported by Suter and De Jong supports the theory of stasis of food as discussed by analysing the reflux symptoms (17,19). In line with the observed effects of adjustable gastric banding on reflux symptoms and esophagitis, pH studies have shown that in some patients without reflux disease preoperatively the operation induces reflux disease, whereas in other patients pre-existing reflux disease is improved or cured by the procedure (19,20). Other (not included) studies found also newly developed pathological reflux in 23% and 54.5% (16,28). ESOPHAGITIS In general a positive effect of gastric banding on esophagitis was reported. Only the study of Suter et al found an increase in reflux esophagitis, however not statistically significant. Newly developed esophagitis (17,18) resembled the pattern found in the analysis of reflux symptoms. The postoperative incidence of esophagitis could even be higher because not all patients had a follow-up endoscopy. Esophagitis after gastric banding was also found to be related to the presence of pouch dilatation (18,25,40). However, others did not find such relationship (17). ESOPHAGEAL MOTILITY The studies using esophageal manometry revealed an overall increase in LES pressure, with a decrease in LES relaxation in nearly all studies. An increase in percentage of dysmotility was reported by most authors (15,17,20). Others found no increase in dysmotility (18,42). The reason for these differences are not clear but the position of the band may play a role because impaired peristalsis was found more frequently after esophagogastric banding (placement of the band at the gastroesophageal junction) (27). Klaus and coworkers (also from the Weiss group) found an association between an increase in defective propagation of esophageal contractions after band placement and more severe reflux problems postoperatively (28). Whereas a clear relationship between low LES pressure and abnormal esophageal acid exposure was found by some (25), others did not support this finding (17) In this study we systematically reviewed the influence of adjustable gastric banding on gastroesophageal reflux and esophageal motility. The studies used in this review were prospective but
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non-randomised studies. Therefore the evidence is not very strong. The different follow-up periods, different techniques of band placement and the relatively small numbers of patients participating in pH monitoring, endoscopy, and manometry studies are important factors which should be kept in mind interpreting the outcome of this review. Future research should focus on the mechanisms in which gastric banding influences gastroesophageal reflux and which factors induce newly developed reflux in subjects without reflux preoperatively. Conclusions: Adjustable gastric banding has anti-reflux properties especially on the short term. However, worsening or newly developed reflux symptoms are found in a subset of patients during longer follow-up. Adjustable gastric banding increases LES pressure and length, but decreases LES relaxation and is associated with an increase in disturbed esophageal peristalsis. REFERENCES
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1. Hampel H, Neena SA, El-Serag HB. Meta-analysis: Obesity and the risk for gastroesophageal reflux disease and its complications. Ann Int Med 2005; 143:199-211 2. El-Serag HB, Graham DY, Satia JA, et al. Obesity is an independent risk factor for GERD symptoms and erosive esophagitis. Am J Gastroenterol 2005; 100:1243-50 3. Wilson LJ, Wenzhou M, Hirschowitz BI. Association of obestity with hiatal hernia and esophagitis. Am J Gastroenterol 1999; 94:2840-44 4. Suter M, Dorta G, Giusti V, et al. Gastro-esophageal reflux and esophageal motility disorders in morbidly obese patients. Obes Surg 2004; 14:959-66 5. Lundell L, Ruth M, Olbe L. Vertical banded gastroplasty or gastric banding for morbid obesity: effects on gastro-oesophageal reflux. Eur J Surg 1997; 163:525-31 6. Lagergren J, Bergstrom R, Nyren O. No relation between body mass and gastrooesophageal reflux symptoms in a Swedish population based study. Gut 2000; 47:26-9 7. Kjellin A, Ramel S, Rossner S. Gastroesophageal reflux in obese patients is not reduced by weight reduction. Scand J Gastroenterol 1996; 31:1047-51 8. Mathus Vliegen EM, Tytgat GN. Gastro-oesophageal reflux in obese subjects: influence of overweight, weight loss and chronic gastric balloon distension. Scand J Gastroenterol. 2002; 11:1246-52. 9. Brolin RE. NIH Consensus Development Panel: Gastrointestinal surgery for severe obesity. Nutrition 1996; 12:403-4 10. Ovrebo KK, Hatlebakk JG, Viste A, et al. Gastroesophagel reflux in morbidly obese patients treated with gastric banding or vertical banded gastroplasty. Ann Surg 1998; 228:51-8 11. Naslund E, Stockeld D, Granstrom L, et al. Six cases of Barrett’s esophagus after gastric restrictive surgery for massive obesity: an extended case report. Obes Surg 1996; 6:155-8 12. Downie JRF. Ulcerating oesophagitis as a late complication of gastroplasty. Obes Surg 1991; 1:108 (abstract) 13. Balsiger BM, Murr MM, Mai J, et al. Gastroesophageal reflux after intact vertical banded gastroplasty correction by conversion to Roux-en-Y gastric bypass. J Gastrointest Surg 2000; 4:276-81 14. Fisher BL. Erosive esophagitis following horizontal gastroplasty for morbid obesity: Treatment by gastric bypass Obes Surg 1994; 4:370-5 15. Weiss HG, Nehoda H, Labeck B, et al. Treatment of morbid obesity with laparoscopic adjustable gastric banding affects esophageal motility. Am J Surg 2000; 180:479-82 16. Gutschow CA, Collet P, Prenzel K, et al. Long-term results and gastroesophageal reflux in a series of laparoscopic adjustable gastric banding. J Gastrointest Surg 2005; 9:941-8 17. Suter M, Dorta G, Giusti V, et al. Gastric banding interferes with esophageal motility and gastroesophageal reflux. Arch Surg 2005; 140:639-43 18. De Jong JR, Van Ramshorst B, Timmer R, et al. Effect of laparoscopic gastric banding on esophageal motility. Obes Surg 2006; 16:52-8 19. De Jong JR, Van Ramshorst B, Timmer R, et al. The influence of laparoscopic adjustable gastric banding on gastroesophageal reflux. Obes Surg 2004; 14:399-406
20. Tolonen P, Victorzon M, Niemi R, et al. Does gastric banding for morbid obesity reduce or increase gastroesophageal reflux? Obes Surg 2006; 16:1469-74 21. Angrisani L, Iovino P, Lorenzo M, et al. Treatment of morbid obesity and gastroesophageal reflux with hiatal hernia by Lap-Band. Obes Surg 1999; 9:396-8 22. Dolan K, Finch R, Fielding G. Laparoscopic gastric banding and crural repair in the obese patients with a hiatal hernia. Obes Surg 2003; 13:772-5 23. Dixon JB, O’Brien PE. Gastroesophageal reflux in obesity: the effect of Lap-Band placement. Obes Surg 1999; 9:527-31 24. O’Brien PE, Dixon JB, Brown W, et al. The laparoscopic adjustable gastric band (Lap-Band): a prospective study of medium-term effects on weight, health and quality of life. Obes Surg 2002; 12:652-60 25. Iovino P, Angrisani L, Tremolaterra F, et al. Abnormal esophageal acid exposure is common in morbidly obese patients and improves after a successful Lap-band system implantation. Surg Endosc 2002; 16:16315 26. Himpens J, Dapri G, Cadiere GB. A prospective randomised study between laparoscopic gastric banding and laparosocpic isolated sleeve gastrectomy. Results after 1 and 3 years. Obes Surg 2006; 16:1450-6 27. Weiss HG, Nehoda H, Labeck B, et al. Adjustable gastric and esophagogastric banding: a randomized clinical trial. Obes Surg 2002; 12:573-8 28. Klaus A, Gruber I, Wetscher G, et al. Prevalent esophageal body motility disorders underlie aggravation of GERD symptoms in morbidly obese patients following adjustable gastric banding. Arch Surg 2006; 141:247-51 29. Weiss H, Labeck B, Klocker J, et al. Effects of adjustable gastric banding on altered gut neuropeptide levels in morbidly obese patients. Obes Surg 2001; 11:735-9 30. Restuccia A, Elmore U, Perrotta N, et al. Endoscopic assessment in patients undergone laparoscopic gastric banding. Obes Surg 1998; 8:398 (abstract) 31. Frigg A, Peterli R, Zynamon A, et al. Radiologic and endoscopic evaluation for laparoscopic adjustable gastric banding: preoperative and follow-up. Obes Surg. 2001; 11:594-9 32. Westling A, Bjurling K, Ohrvall M, et al. Silicone adjustable gastric banding: disappointing results. Obes Surg 1998; 8:467-74 33. Victorzon M, Tolonen P. Intermediate results following laparoscopic adjustable gastric banding for morbid obesity. Dig Surg 2002; 19:354-8 34. Anderson P. Endoscopic and histological evaluation of the Lap-Band at 12 months. Obes Surg 1999; 9:330 (abstract) 35. Korenkov M, Kohler L, Yucel N, et al. Esophageal motility and reflux symptoms before and after bariatric surgery. Obes Surg 2002; 12:72-6 36. Bonavina L, DeMeester T, Mason R, et al. Mechanical effect of the Angelchik prosthesis on the competency of the gastric cardia: pathophysiologic implications and surgical perspectives. Dis Esoph 1997; 10:115-8 37. Lew JI, Daud A, DiGorgi MF, et al. Preoperative esophageal manometry and outcome of laparoscopic adjustable silicone gastric banding. Surg Endosc 2006; 20:1242-7 38. Spivak H, Hewitt MF, et al. Weight loss and improvement of obesity-related illness in 500 U.S. patients following laparoscopic adjustable gastric banding procedure. Am J Surg 2005; 189:27-32 39. Frigg A, Peterli R, Peters T, et al. Reduction in co-morbidities 4 years after laparoscopic adjustable gastric banding. Obes Surg 2004; 14:216-23 40. Forsell P, Hallerback B, Gilse H, et al. Complications following swedish adjustable gastric banding: a long term follow-up. Obes Surg 1999; 9:11-6 41. Niville E, Vankeirsbilck J, Dams A, et al. Laparoscopic adjustable esophagogastric banding: a preliminary experience. Obes Surg. 1998 Feb; 8(1):39-43. 42. O’Brien PE, Dixon JB. Lap-band: outcomes and results. J. Laparoendosc Adv Surg Tech A 2003:13:265-70 43. Ahroni JH, Montgomery KF, Watkins BM. Laparoscopic adjustable gastric banding: weight loss, co-morbidities, medication usage and quality of life at one year. Obes Surg 2005; 15:641-7
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Chapter 8 SUMMARY, CONCLUSIONS AND FUTURE PERSPECTIVES
In Chapter 1 a general introduction was given about the epidemiology of obesity, the relationship between obesity and gastroesophageal reflux and laparoscopic adjustable gastric banding. Obesity has increased markedly since 1980 and has gained epidemic proportions worldwide. The increasing prevalence of obesity is a threat for the public health as it is related to several chronic morbidities and disabilities. Bariatric surgery is the only treatment option for individuals who have clinically severe obesity and are at the high risk for obesity-related mortality and co-morbidity. The number of bariatric surgery procedures has increased significantly over the past few decades. Nowadays one of the most performed surgical procedures for treatment of morbid obesity is the laparoscopic adjustable silicone gastric banding (LASGB). In the late 1990s it was reported that laparoscopic adjustable gastric and esophagogastric banding resulted in a decrease or resolution of gastroesophageal reflux symptoms. However, these studies were lacking objective measurements like pH recording and esophageal manometry. In order to get more insight in the effect of laparoscopic adjustable gastric banding on gastroesesophageal reflux we started our studies in morbidly obese patients who were candidates for laparoscopic adjustable gastric banding in the St Antonius Hospital in Nieuwegein. The results of these studies are described in this thesis.
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In Chapter 2 we studied the effect of LASGB on gastroesophageal reflux. Twenty-six patients undergoing gastric banding were assessed by a questionnaire for symptom analysis, 24-hour pH monitoring, endoscopy and barium swallows, preoperatively, at 6 weeks and at 6 months after operation. Gastric banding had minimal effect on heartburn scores but regurgitation and belching scores increased significantly during follow-up. Use of acid-reducing drugs was decreased significantly at 6 weeks and increased significantly at 6 months. Pathological reflux was present in 13 of the 26 patients preoperatively. At 6 months pathological reflux was found in only 6 of these 13 patients, but 4 of the 13 patients with preoperatively normal reflux patterns had developed pathological reflux. Six months after the operation esophagitis had disappeared in 6 patients and was increased in 9 patients. In 9 patients a pouch dilatation was found at 6 months. Pouch dilatation was significantly correlated with the presence of pathological reflux, esophagitis and the use of acid-reducing medication. Pre-operative presence of a hiatal hernia did not influence pouch dilatation or pathological reflux. It was concluded that LASGB decreases gastroesophageal reflux if there is no pouch formation during follow-up. Alterations in esophageal motility may occur after placement of an adjustable gastric band near the gastroesophageal junction. The band may cause obstruction especially during follow-up after the band is filled. In Chapter 3 we studied the effect of LASGB on esophageal motility and lower esophageal sphincter functioning. Twenty-nine morbidly obese patients underwent conventional manometry preoperatively, six weeks postoperatively before and after filling the band and at six months postoperatively. A questionnaire was used to assess upper gastrointestinal symptoms during follow-up. After band placement, there was a significant increase in lower esophageal sphincter (LES) endexpiratory pressure at six weeks with an empty band: 1.3 (0.9-1.9) kPa (median(interquartile range) (p = 0.003), six weeks with a filled band: 2.1 (1.5-2.8) kPa (p = 0.0001) and at six months: 1.5 (1.3-1.9) kPa (p = 0.001) after band placement compared to the preoperative pressure: 0.8 (0.6-
1.3) kPa . The length of the high-pressure zone also increased after band placement (preop 5.0 (4.3-6.0)cm vs six weeks 6.0 (5.0-6.5) cm (p = 0.003). The propagation of peristaltic contractions was not significantly altered after band placement. Heartburn decreased six weeks postoperatively (p = 0.04) but increased at six months. Heartburn at six months was correlated with pouch formation (0.667; p < 0.01). We concluded that adjustable gastric band placement causes an increase in LES pressure and highpressure zone length. It decreases reflux symptoms on the short term but this effect appears not to be related with an effect on LES pressure or length. Pouch formation increases reflux symptoms without having any relationship with LES pressure and length. Band placement on the short term does not disturb propagation of esophageal contractions. In Chapter 4 the role of gastric emptying in the mechanism of weight loss and early satiety was studied in a consecutive series of patients who were scintigraphically investigated before and after LASGB. Sixteen patients undergoing LASGB underwent a gastric emptying study (solid meal, single isotope) preoperatively and at six months postoperatively. Esophageal retention time, lag phase, peak activity time, gastric emptying rate, fundus emptying rate and weight loss were recorded. Upper gastrointestinal (GI) symptom assessment was carried out by use of a standardized questionnaire. Gastric emptying parameters were correlated with the upper GI symptoms. Gastric band placement showed no significant influence on postoperative gastric emptying rate and fundus emptying rate, however an increase in early satiety was found. Neither gastric emptying rate nor fundus emptying rate showed a relation with early satiety or weight loss. Also no correlation was found between early satiety and lag phase, esophageal retention time, start of activity and peak activity time in the proximal stomach. It was concluded that LASGB does not affect gastric emptying. Neither a relation between postoperative gastric emptying rate and weight loss, nor between early satiety and weight loss was found. Therefore, it is unlikely that gastric emptying plays a role in the mechanism of weight loss following LASGB. In Chapter 5 the occurrence of esophageal dilatation after LASGB was investigated. Forty-five patients after LASGB were assessed for the development of esophageal dilatation by standardised barium swallow studies carried out after the operation and after a mean follow-up period of 39.3 months. The diameter of the esophagus postoperatively and during follow-up was calculated in millimeters by using the known diameter of the gastric band. An increase in diameter > 130% compared to the postoperative diameter was considered as dilatation. Symptoms were assessed by a questionnaire. In 11 patients with dilatation the band was emptied and a barium swallow performed in order to assess whether the dilatation was reversible. A significant increase in the esophageal diameter (median (interquartile range) was found comparing the early postoperative and follow-up data: 16.3 (14-18.7) mm vs. 20.7 (18.1-26.8)mm (p < 0.01). In 25 of the 45 patients (55.6%) the dilatation percentage exceeded 130%. In 7 of the 11 patients the dilatation after emptying of the band still exceeded 130%. The increase of esophageal diameter was significantly correlated with the duration of follow-up, with regurgitation, heartburn during nighttime, and slow esophageal clearance. It was concluded that LASGB causes esophageal dilatation in about half of the patients. This dilatation is correlated with symptoms and is partly reversible after emptying of the band. The clinical relevance of the dilatation is unclear. In Chapter 6 we retrospectively analysed the results of the LASGB procedure for morbid obesity in 411 patients. Height, weight, and complications were prospectively recorded. The study group
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consisted of 350 (85%) women and 61 (I5%) men with a median age of 38 years (range 17-60). In these 411 patients, the median weight was 133.4 kg, the median overweight 69.6 kg and the median BMI 46.3 kg/m2. Two years after surgery, data was available for 267 patients 206 (77%) of whom had a weight loss > 30%, and 7 patients (3%) a weight gain. The median BMI difference was then -10.2 kg/m2 (range +4.7—26.4). The median loss of overweight was 46.3% (+10.00— 97.8). The weight loss remained stable in the following years. The most commonly seen complications were fundus slippage (13%) and port-related complications (7%). It was concluded that three quarters of the patients with morbid obesity who received LASGB surgery had achieved and sustained weight loss at 2 years following surgery.
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Controversial opinions exist concerning the effect of gastric banding on gastroesophageal reflux. In Chapter 7 we performed a systematic review on the the effect of LASGB on gastroesophageal reflux and esophageal motility. MEDLINE and EMBASE databases were searched for relevant studies on patients undergoing adjustable gastric banding. Outcome measures were: reflux symptoms, medication use, esophagitis, pathological reflux measured by pH recording, LES (lower esophageal sphincter) function and esophageal peristalsis. Data were expressed as mean (range). Seventeen studies were identified with a total of 1839 patients. The prevalence of reflux symptoms decreased postoperatively from 32.2% (16-48.4) to 9.1% ( 0-26.9) and medication use from 27.5% ( 16-38.5) to 9.5% (3.1-19.2). Newly developed reflux symptoms were found in 15% (6.1-20) of the patients. The percentage of esophagitis decreased postoperatively from 33.3% (19.4-61.6) to 27% (2.3-60.8). Newly developed esophagitis was observed in 22.9% (038.4). Pathological reflux was found 55.8% (34.9-77.4) preoperatively and postoperatively in 29.4% (0-41.7). LES pressures increased from 12.9 mmHg (6-22) to 16.9 mmHg (11.3-21.4). LES relaxation decreased from 100% to 79.7% (58-86). The percentage of dysmotility increased from 3.5% (0-10) to12.6% (0-25). It was concluded that LASGB has anti-reflux properties resulting in resolution or improvement of reflux symptoms, normalized pH monitoring results and a decrease of esophagitis. However, worsening or newly developed reflux symptoms and esophagitis are found in a subset of patients during longer follow-up. Pouch dilatation, filling of the band and disordered esophageal motility are possible causative factors. Adjustable gastric banding increases LES pressure, but decreases LES relaxation and is associated with an increase in disturbed esophageal peristalsis.
ANSWERS TO STUDY QUESTIONS OF THIS THESIS Chapter 2 Does laparoscopic adjustable gastric banding affect gastroesophageal reflux? Adjustable gastric banding decreases gastroesophageal reflux, but in a small subset of patients an increase in gastroesophageal reflux will develop. Chapter 3 Does laparoscopic adjustable gastric banding affect esophageal motility? Adjustable gastric band placement causes an increase in LES pressure and high-pressure zone length. Band placement on the short term does not disturb propagation of esophageal contractions. Chapter 4 Is there a change in gastric emptying after laparoscopic adjustable gastric banding and, if so, does this contribute to the weight loss?
Gastric band placement has no significant effect on postoperative gastric emptying rate and fundus emptying rate. Neither gastric emptying rate nor fundus emptying rate showed a relation with early satiety or weight loss. Chapter 5 Does laparoscopic adjustable gastric banding cause esophageal dilatation? LASGB causes esophageal dilatation in about half of the patients. This dilatation is correlated with symptoms and length of follow-up and is partly reversible after emptying of the band. Chapter 6 Do all morbidly obese subjects benefit from adjustable gastric banding? Three quarters of the patients with morbid obesity who underwent laparoscopic gastric banding surgery has sustained weight loss at two years following surgery. In subjects with a BMI > 50 LAGB seems to be less effective than in those with a BMI < 50. FUTURE PERSPECTIVES As identified in chapters 2 and 3, gastric banding influences gastroesophageal reflux. The exact mechanism in which gastric banding decreases and sometimes increases gastroesophageal reflux is unclear and should be elucidated. The role of transient relaxations of the lower esophageal sphincter, pre-existent esophageal motility disorders and weight loss on gastroesophageal reflux postoperatively is not fully understood. Intra-esophageal impedance monitoring, high-resolution manometry and 3-D ultrasound of the LES probably provides more insight in the (patho)-physiology of gastroesophageal reflux after LASGB. In chapter 4 an increase in early satiety was found after LASGB, but a relation with gastric emptying was not demonstrated. The mechanism of early satiety after adjustable gastric banding is important and needs to be unravelled because it is one of the keys in the success of bariatric surgical operations. Alterations of the proximal stomach after gastric band placement by using a fundic wrap to fix the band may play a role by increasing early satiety. Barostat studies possibly will help to identify changes in postprandial accommodation of the proximal stomach and explain the occurrence of early satiety. As identified in chapter 5 LASGB causes esophageal dilatation. However, the definition of esophageal dilatation is unclear and should be further determined and quantified. Long term studies in large groups of patients, in which barium swallows and manometry are performed, are needed, in order to confirm or exclude that decompensation of the esophagus will occur on the long term. In chapter 6 we reported that in three quarters of the patients with morbid obesity who received LASGB, sustained weight loss is achieved at two years following surgery. Patients with extreme obesity (BMI > 50) seems to have less effect of the banding procedure than patients with a BMI < 50. A prospective randomized study is warranted to conclude if it is better for patients with extreme obesity to undergo a gastric bypass procedure instead of a gastric banding procedure.
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Chapter 9 SAMENVATTING, CONCLUSIES EN TOEKOMSTPERSPECTIEVEN
In hoofdstuk 1 wordt een algemene inleiding gegeven over de epidemiologie van overgewicht, de relatie tussen overgewicht en gastro-oesofageale reflux en laparoscopische maagbandplaatsing. Het aantal mensen met overgewicht is enorm toegenomen sinds 1980 en heeft wereldwijd epidemische vormen aangenomen. De toenemende prevalentie van overgewicht is een bedreiging voor de volksgezondheid omdat overgewicht is gerelateerd aan verschillende chronische ziektes en handicaps. Bariatrische chirurgie is de enige effectieve behandeling voor individuën met ernstig overgewicht. Het aantal operaties voor overgewicht is sterk toegenomen in de afgelopen decennia. Op dit moment is de laparoscopische maagbandplaatsing een van de meest uitgevoerde operaties. Eind 90er jaren werd in de literatuur gemeld dat laparoscopische maagbandplaatsing een afname van gastro-oesophageale refluxklachten gaf. Echter, in deze studies ontbraken objectieve metingen zoals pH-meting en manometrie. Om meer inzicht in het effect van laparoscopische maagbandplaatsing op gastro-oesophageale reflux te krijgen werd gestart met onderzoek bij patienten met ziekelijk overgewicht die in aanmerking kwamen voor laparoscopische maagbandplaatsing in het St Antonius Ziekenhuis te Nieuwegein. De resultaten van deze studies zijn beschreven in dit proefschrift.
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In hoofdstuk 2 werd het effect van laparoscopische maagbandplaatsing op gastro-oesofageale reflux bestudeerd. Zesentwintig patiënten die een maagbandplaatsing kregen werden bestudeerd met behulp van: een vragenlijst voor symptoom analyse, 24-uurs pH-meting, oesofagogastroduodenoscopie en oesophagus-passagefoto’s. De onderzoeken werden preoperatief, 6 weken en 6 maanden na de operatie uitgevoerd. Maagbandplaatsing had een gering effect op zuurbranden, maar regurgitatie nam aanzienlijk toe tijdens het vervolgonderzoek. Het gebruik van zuurremmende middelen was 6 weken na de operatie aanzienlijk gedaald maar vertoonde 6 maanden na de operatie een duidelijke stijging. Pathologische reflux was aanwezig bij 13 van de 26 patiënten voor de operatie. Zes maanden na de operatie werd pathologische reflux bij slechts 6 van deze 13 patiënten gemeten, maar 4 van de 13 patiënten met een normaal preoperatief refluxpatroon bleken na 6 maanden pathologische reflux te hebben ontwikkeld. Zes maanden na de operatie was de oesophagitis verdwenen bij 6 patiënten maar toegenomen bij 9 patiënten. Bij 9 patiënten werd 6 maanden na de operatie een pouchvergroting vastgesteld. Pouchvergroting was significant gecorreleerd met de aanwezigheid van pathologische reflux, oesofagitis en het gebruik van zuurremmende medicatie. Pre-operatieve aanwezigheid van een hiatus hernia had geen invloed op de pouchvergroting of pathologische reflux. De conclusie was dat laparoscopische maagbandplaatsing gastro-oesofageale reflux vermindert mits er geen pouchvergroting optreedt na de operatie. Veranderingen in de oesofagusmotiliteit zouden kunnen optreden na plaatsing van een maagband in de buurt van de overgang van oesophagus naar maag doordat er een obstructie wordt veroorzaakt, met name als de maagband wordt opgeblazen. In hoofdstuk 3 onderzochten we het effect van de maagband op de oesofagusmotiliteit en onderste oesofagussfincter. Bij 29 patiënten met ziekelijk overgewicht werd vóór de maagbandplaatsing, zes weken na de operatie (vóór en na het vullen van de band) en zes maanden na de operatie, een manometrie verricht. Een vragenlijst werd gebruikt om de gastro-intestinale symptomen te scoren. Na plaatsing van de maagband was er een significante toename in de druk van de onderste oesofagussfincter. Preoperatief was de druk: 0,8 (0,6-1,3) kPa (mediaan (interquartile range). Na zes weken met een lege band was de druk 1,3 (0.9-1.9) kPa (p = 0,003), na zes weken met een gevulde band was de druk 2,1 (1.5-2.8) kPa (p = 0,0001) en na zes maanden was de druk 1,5 (1.3-1.9) kPa (p = 0,001). Ook de lengte van de hogedrukzone was toegenomen na band- plaats-
ing (preop 5.0 (4.3-6.0) cm vs zes weken 6.0 (5.0-6.5) cm. (p = 0,003). Het aantal peristaltische contracties was niet significant gewijzigd na plaatsing van de band. Zuurbranden werd minder gezien zes weken na de operatie (p = 0,04), maar nam weer toe bij zes maanden. Zuurbranden na 6 maanden was gecorreleerd met pouchvergroting (0,667; p < 0,01). Geconcludeerd werd dat maagbandplaatsing zorgt voor een toename in de druk van de onderste oesofagussfincter en een langere hogedrukzone bewerkstelligt. Maagbandplaatsing vermindert refluxsymptomen op de korte termijn maar dit lijkt niet te zijn gecorreleerd met druk of lengte van de onderste oesofagussfincter. Pouchvorming veroorzaakt een toename van reflux-symptomen, zonder dat er een relatie is met druk en lengte van de onderste oesofagussfincter. Maagband plaatsing verstoort de oesfagusperistaltiek niet, althans niet op korte termijn. In hoofdstuk 4 werd de rol van de maagontlediging bij gewichtsverlies en vroege verzadiging onderzocht in een opeenvolgende reeks van patiënten. Zestien patiënten ondergingen preoperatief en zes maanden na maagbandplaatsing een maagontledigingsonderzoek (vast voedsel, enkel isotoop). Oesofagus-retentietijd, ”lag phase”, tijd tot maximum aktiviteit, maagontledigingssnelheid, fundusontledigingssnelheid en gewichtsverlies werden gemeten. Symptoomanalyse werd uitgevoerd met behulp van een gestandaardiseerde vragenlijst. Maagontledigingsparameters werden gecorreleerd met de symptomen. Maagbandplaatsing bleek geen significante invloed te hebben op de postoperatieve maag-en fundusontledigingssnelheid. Wel werd een significante toename van vroege verzadiging gerapporteerd. De snelheid van maag-en fundusontlediging bleken geen relatie te hebben met het optreden van vroege verzadiging of gewichtsverlies. Ook werd er geen relatie gevonden tussen vroege verzadiging met lag phase, oesofagusretentietijd, start van de activiteit en de maximale activiteit in proximale maag. Geconcludeerd werd dat maagbandplaasting geen significante invloed heeft op maagontledigingssnelheid. Daarom is het onwaarschijnlijk dat de snelheid van maaglediging een rol speelt bij het mechanisme van gewichtsverlies na maagbandplaatsing. In hoofdstuk 5 werd bij 45 patiënten het optreden van oesofagusdilatatie na maagbandplaatsing onderzocht met behulp van gestandaardiseerde slikfoto’s. De vervolgslikfoto’s werden gemiddeld 39,3 maanden na de eerste slikfoto gemaakt. De diameter van de slokdarm werd gemeten in millimeters waarbij de bekende vaste diameter van de maagband werd gebruikt als referentiepunt. Een toename van de diameter van 130% ten opzichte van de diameter net na de operatie werd beschouwd als slokdarmverwijding. Symptomen werden beoordeeld door middel van een vragenlijst. Bij 11 patiënten met een verwijding van de slokdarm werd de maagband geleegd waarna opnieuw een slikfoto werd gemaakt met het doel te beoordelen of de slokdarmverwijding omkeerbaar was. Voor de hele groep werd er een significante stijging van de oesofagus diameter (mediaan (interquartile range) gevonden wanneer de slikfoto’s direkt na de operatie werden vergelekn met de latere slikfoto’s: 16,3 (14-18,7) mm versus 20,7 (18,1-26,8) mm (p < 0,01). Bij 25 van de 45 patiënten (55,6%) was er sprake van dilatatie-percentage > 130%. In 7 van de 11 patiënten bleek dat er na het legen van de band nog steeds sprake was van een diameter- toename van > 130%. De toename van de oesofagusdiameter was significant gecorreleerd met duur van de follow-up, regurgitatie, nachtelijk zuurbranden, en vertraagde oesofagus- lediging. De conclusie was dat maagbandplaatsing oesofagusdilatatie veroorzaakt bij ongeveer de helft van de patiënten. Deze verwijding is gecorreleerd met symptomen en is gedeeltelijk reversibel na het legen van de band. De klinische relevantie van de slokdarmverwijding is onduidelijk. In hoofdstuk 6 werden bij 411 patienten retrospectief de resultaten van laparoscopische maagbandplaatsing beoordeeld. Van deze 411 patiënten was het mediane gewicht 133,4 kg, het medi-
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ane overgewicht 69,6 kg en de mediane BMI 46,3 kg/m2. Van 267 patiënten waren gegevens bekend 2 jaar na de operatie. Twee jaar na de operatie hadden 206 patiënten (77%) een overgewichtsverlies > 30% en 7 patiënten (3%) een gewichtstoename. De mediane afname van het overgewicht was 46,3% (+10,0-–97,8). Het gewichtsverlies was in de jaren erna stabiel. De meest frequente complicaties waren fundusherniatie (13%) en problemen met de “port” (7%). Deze deden zich vaker voor bij de perigastrische methode dan bij de pars-flaccidatechniek. Geconcludeerd werd dat na laparoscopische maagbandplaatsing wegens morbide obesitas bij driekwart van de patiënten een duurzaam gewichtsverlies bereikt wordt. De pars-flaccidatechniek gaat met minder complicaties gepaard dan de perigastrische methode.
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In de literatuur vindt men verdeelde meningen betreffende de invloed van maagbandplaatsing op gastro-oesofageale reflux. In hoofdstuk 7 beschreven wij een systematische review over het effect van maagbandplaatsing op gastro-oesofageale reflux en oesofagus motiliteit. MEDLINE en EMBASE databases werden doorzocht voor relevante studies over maagbandplaatsing en gastrooesofageale reflux. Punten van onderzoek waren: refluxsymptomen, medicatie gebruik, oesophagitis, pathologische reflux gemeten met 24-uurs pH-metingen, onderste oesofagussfincterfunctie en oesofagusperistaltiek. Gegevens werden uitgedrukt als gemiddelden (range). Zeventien studies met een totaal van 1.839 patiënten voldeden aan de selectiecriteria. De prevalentie van reflux-symptomen na de operatie daalde van 32,2% (16-48.4) tot 9,1% (0-26,9) en medicatiegebruik van 27,5% (16-38.5) tot 9,5% (3,1-19,2). Nieuw ontwikkelde reflux-symptomen werden gemeld door 15% (6.1-20) van de patiënten. Het percentage oesofagitis postoperatief daalde van 33,3% (19.4-61.6) tot 27% (2.3-60.8). Nieuw ontwikkelde oesophagitis werd waargenomen bij 22,9% (0-38,4) van de patienten. Pathologische reflux werd gevonden bij 55,8% (34.9-77.4) voor- en na de operatie bij 29,4% (0-41,7) van de patienten. De druk in de onderste oesophagussfincter nam toe van 12,9 mmHg (6-22) tot 16,9 mmHg (11.3-21.4). Het relaxatie-percentage van de onderste oesofagussfincter daalde van 100% naar 79,7% (58-86). Het percentage dysmotiliteit steeg van 3,5% (0-10) to12.6% (0-25). De conclusie was dat maagbandplaatsing kan leiden tot het verdwijnen of verminderen van refluxsymptomen, het normaliseren van pH-metingen en een afname van oesophagitis. Echter, gedurende langere follow-up werden ook verslechtering of nieuw ontwikkelde refluxsymptomen en oesofagitis gevonden in een subgroep van patiënten. Hierbij zijn pouch-vergroting, het vullen van de band en verstoorde oesofagusmotiliteit mogelijke oorzakelijke factoren. Maagbandplaatsing verhoogt de druk in de onderste oesofagussfincter vermindert de mogelijkheid tot sfincterrelaxatie en wordt geassocieerd met een toename van gestoorde oesofagusperistaltiek.
STUDIEVRAGEN EN ANTWOORDEN OP DEZE VRAGEN Hoofdstuk 2 Beinvloedt laparoscopische maagbandplaatsing gastro-oesofageale reflux? Laparoscopische maagbandplaatsing vermindert gastro-oesofageale reflux als er geen pouch-vergroting ontstaat. Echter, in een kleine groep patienten ontstaat gastro-oesofageale reflux. Hoofdstuk 3 Heeft laparoscopische maagbandplaatsing invloed op de oesofagusmotiliteit? Maagbandplaatsing zorgt voor een toename in de druk van de onderste oesofagussfincter en voor een langere hogedrukzone. Bandplaatsing verstoort op de korte termijn de oesofagus- peristaltiek niet.
Hoofdstuk 4 Verandert de maagontlediging na laparoscopische maagbandplaatsing en draagt dit bij aan het gewichtsverlies? Maagbandplaatsing bleek geen significante invloed op de postoperatieve maag-en fundusontledigingssnelheid te hebben. Zowel maag- als fundusontledigingssnelheid bleken geen relatie te hebben met het optreden van vroege verzadiging of gewichtsverlies. Hoofdstuk 5 Veroorzaakt laparoscopische maagbandplaatsing oesofagusverwijding? Maagbandplaatsing veroorzaakt bij ongeveer de helft van de patienten een oesofagus-verwijding. Deze verwijding is gecorreleerd met symptomen en is gedeeltelijk reversibel na het legen van de maagband. Hoofdstuk 6 Hebben alle patienten met ziekelijk overgewicht baat bij een maagbandplaatsing? Driekwart van de patiënten met ziekelijk overgewicht die een maagband geplaatst krijgen, hebben een blijvend gewichtsverlies 2 jaar na de operatie. Mensen met een BMI > 50 lijken minder baat te hebben bij een maagband dan mensen met een BMI < 50. TOEKOMSTIG ONDERZOEK Zoals beschreven in de hoofdstukken 2 en 3, beïnvloedt maagbandplaatsing gastro-oesofageale reflux. Het exacte mechanisme waardoor de maagband zorgt voor afname en soms voor toename van gastro-oesofageale reflux is onduidelijk. De rol hierbij van transiente relaxaties van de onderste oesofagussfincter, pre-existente oesofagusmotiliteitstoornissen en gewichtsverlies is nog onvoldoende onderzocht. Impedantiemeting, hoge-resolutie manometrie en 3-D echografie van de onderste oesofagussfincter zouden meer inzicht kunnen geven in de (patho)fysiologie van gastro-oesofageale reflux na maagbandplaatsing. In hoofdstuk 4 bleek dat maagbandplaatsing gepaard gaat met toename van gevoelens van vroege verzadiging tijdens de maaltijd, maar een relatie met de maagontlediging werd niet aangetoond. Het mechanisme van vroegtijdige verzadiging is belangrijk en dient te worden ontrafeld daar het de sleutel tot succes is van de chirurgische behandeling van overgewicht. Veranderingen van de proximale maag na maagbandplaatsing waarbij een deel van de fundus wordt gebruikt om de band te borgen zouden een rol kunnen spelen bij het ontstaan van vroege verzadiging. Barostatstudies zouden een rol kunnen spelen bij het meten van veranderingen van de proximale maag. In hoofdstuk 5 werd beschreven dat maagbandplaatsing oesofagusdilatatie kan veroorzaken. De definitie van oesofagusdilatatie en klinische relevantie is onduidelijk en moet worden vastgesteld. Lange termijn studies bij een groot aantal patiënten, waarbij slikfoto’s en manometrie worden gebruikt, zijn nodig om te bevestigen of er op de lange termijn er decompensatie van de oesofagus optreedt. In hoofdstuk 6 hebben wij gemeld dat bij driekwart van de patiënten met morbide obesitas die een laparoscopische maagband kregen er een blijvend gewichtsverlies is opgetreden 2 jaar na de operatie. Patiënten met extreem overgewicht (BMI > 50) leken minder effect te hebben van de maagband dan patiënten met een BMI < 50. Een prospectieve gerandomiseerde studie is nodig om vast te stellen of het beter is voor patiënten met extreem overgewicht om een gastric-bypassprocedure te ondergaan in plaats van een maagbandprocedure.
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DANKWOORD Een dankwoord voor velen aan het einde van een lang promotietraject is zeker op zijn plaats. Iedereen heeft veel geduld moeten hebben. Maar nu is het dan zover. Onderzoek doen, de opleiding tot chirurg volgen, en dan ook nog trouwen en vader worden, was soms wat veel van het goede. Meer dan tachtig procent van mijn proefschrift is geschreven na elf uur ’s avonds. Een proefschrift schrijven is daarom, naast een wetenschappelijke uitdaging, ook zeker een proeve van doorzettingsvermogen. Velen hebben hun steentje bijgedragen maar uiteindelijk moet je het wel zelf doen. Een aantal mensen wil ik in het bijzonder noemen. Prof. Smout, beste André, zeer veel dank voor al je bemoeienissen. Je bent de grote motor geweest achter de diverse manuscripten. Uiteindelijk is het toch afgekomen. Als ik weer eens een dip had en met je sprak zag ik het altijd weer zitten. Een historisch moment is aangebroken, zoals je pas schreef. Je humor en verbazingwekkende vermogen teksten te herordenen en boven het niveau van het Wim Kok Engels uit te tillen verdienen veel waardering. Na een indringende mail van jou eind vorig jaar bleek ik toch wel snel te kunnen werken… Prof. Gooszen, beste Hein, als niet geboren wetenschapper ben ik, mede dankzij jouw opmerkingen bij de diverse manuscripten en je tip om Marc Besselink eens te raadplegen betreffende de systematic review, er uiteindelijk in geslaagd een boekje af te leveren.
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Dr. Timmer, beste Robin, jij stond aan de basis van dit proefschrift. Van jou heb ik geleerd hoe je een manometrie en pH-metrie moet verrichten en interpreteren. De liefde voor de gastroenterologie is hierna niet meer overgegaan. Ook als kinderchirurg ligt mijn interesse bij kinderen met stoornissen van het maag- darmstelsel. Dr B. van Ramshorst, beste Bert, het is zover. Ook jij bent vanaf het begin bij dit proefschrift betrokken geweest. Je enorme werklust en werktempo heeft je tot een van de bekendste bariatrisch chirurgen in Nederland gemaakt. Ik denk nog met plezier terug aan al die mooie congressen op mooie plaatsen waar we gebivakkeerd hebben. Ik hoop dat je rode oor rechts na al die verhalen van mij op de terugweg uit Salzburg weer zijn normale kleur heeft gekregen. Afdeling Endoscopie in het St Antonius Ziekenhuis, dank voor de gastvrijheid die ik mocht ervaren tijdens het uitvoeren van mijn metingen. Afdeling Radiologie, Cas Tiethof en Ruud de Graaf, inmiddels ook oud- Antonianen. Dank voor jullie bijdrage en tijd bij het uitvoeren van de dilatatiestudie. Afdeling Nucleaire Geneeskunde, Dr. Monique van Buul, bedankt voor je geduld om mij iets te leren over maagontlediging. Dank ook aan de laboranten, in het bijzonder Marielle Otten, die elke keer weer mijn patiënten moest inplannen. Wouter te Riele, medeonderzoeker, dank voor je inspanning betreffende het resultatenartikel. Succes met het afronden van je eigen boekje.
Het hele proefschrift was niets geworden zonder de patiënten die hebben meegewerkt aan de diverse studies. Misschien denken ze nog wel eens aan die dokter De Jong die weer belde voor even een meting met die slangetjes door de neus. Niet één keer, maar wel vijf of soms zes keer. Brigitte Bliemer, nurse practicioner, bedankt voor het bijhouden van de database en het af en toe aanleveren van gegevens. De beoordelingscommissie, Prof. Ter Braak, Prof. Akkermans, Prof. Kon, Prof. Van der Graaf en Prof. Greve. wil ik bedanken voor het beoordelen van mijn manuscript. Ik hoef niemand te bedanken voor het geven van extra vrije tijd voor onderzoek, want studieverlof heb ik nooit gekregen. Paranimfen Rob en Wouter, oud-huisgenoten, het doet me deugd jullie als paranimfen aan mijn zijde te hebben. Ik hoop dat onze vriendschap nog zeer lang mag blijven bestaan. Lieve Scheltine, je wilde me graag helpen. Ik wilde dat ik wat van je scherpe analytische geest had, dan was het boekje vast eerder klaar geweest. Lieve Joep, Guido en Maartje, eindelijk heeft papa zijn boekje af en dat ondanks jullie…A Tot slot citeer ik een gedeelte uit het eerste boek van de Confessiones van Augustinus waarin iets gezegd wordt over mijn inspiratiebron: Magnus es, domine, et laudabilis valde (…) inquietum est cor nostrum donec requiescat in te. Groot zijt Gij, Heer, en alle lof waardig (…) onrustig is ons hart totdat het rust vindt in U.
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CURRICULUM VITAE Justus Reinier (Justin) de Jong werd op 9 januari 1970 geboren in Kockengen. In 1988 haalde hij zijn VWO diploma op het Van Lodenstein College te Amersfoort. Aansluitend studeerde hij Geneeskunde in Utrecht waar hij in 1996 zijn artsenbul ontving. Hierna werkte hij als AGNIO Chirurgie in het St Elizabeth Ziekenhuis te Amersfoort en het St Antonius Ziekenhuis te Nieuwegein. In januari 1999 startte hij met de opleiding Heelkunde in het St Antonius Ziekenhuis te Nieuwegein (opleider dr. P.M.N.Y.H. Go). In deze tijd werd het onderzoek gestart dat geleid heeft tot dit proefschrift. Vanaf 2002 tot 2005 werd de opleiding Heelkunde vervolgd in het Academisch Ziekenhuis te Utrecht (Opleider Prof. dr. I.H.M. Borel Rinkes). De vervolgopleiding tot kinderchirurg vond plaats in het Wilhelmina Kinderziekenhuis te Utrecht (opleiders Prof. dr. N.M.A. Bax en dr. D.C. van der Zee) en in het Kinderchirurgisch Centrum te Amsterdam (Opleider prof. dr. H.A. Heij). Na een jaar in Utrecht en Maastricht te hebben gewerkt als kinderchirurg is Justin sinds 2009 opgenomen in de staf van het Kinderchirurgisch Centrum te Amsterdam. Justin woont in Linschoten en is getrouwd met Scheltine Suur. Samen hebben zij drie kinderen: Joep, Guido en Maartje.
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Prof. dr. L.M.A. Akkermans Afdeling Experimentele Heelkunde, Universitair Medisch Centrum, Utrecht Prof. dr. M. Kon Afdeling Plastische en Reconstructieve Chirurgie, Universitair Medisch Centrum, Utrecht Prof. dr. E.W.M.T. ter Braak Afdeling Interne Geneeskunde, Universitair Medisch Centrum, Utrecht Prof. dr. Y. van der Graaf Julius Centrum voor Gezondheidswetenschappen en Eerstelijns Geneeskunde, Universitair Medisch Centrum, Utrecht Prof. dr. J.W. Greve Universitair Medisch Centrum, Maastricht, Atrium Medisch Centrum Heerlen
