Obesity Surgery https://doi.org/10.1007/s11695-018-3220-1
ORIGINAL CONTRIBUTIONS
Laparoscopic Gastric Bypass with Fundectomy and Gastric Remnant Exploration (LRYGBfse): Results at 5-Year Follow-up Giovanni Lesti 1 & Alberto Aiolfi 2 & Enrico Mozzi 3 & Fabrizio Altorio 1 & Ezio Lattuada 4 & Francesco Lesti 1 & Gianluca Bonitta 2 & Marco Antonio Zappa 5
# Springer Science+Business Media, LLC, part of Springer Nature 2018
Abstract Background The laparoscopic Roux-en-Y gastric bypass (LRYGB) is the gold standard treatment for morbid obesity. After LRYGB, the endoscopic access to the gastric remnant and pancreaticobiliary system is challenging. The laparoscopic gastric bypass with fundectomy and exploration of the gastric remnant (LRYGBfse) was introduced in an attempt to overcome this limitation. The purpose of this study was to analyze the medium-term outcomes and safety of LRYGBfse. Methods Observational prospective single-arm multicenter cohort study. Patients with BMI > 35 kg/m2 were included. Previous open abdominal surgery was an exclusion criterion. Postoperative 1, 2, 3, and 5-year weight loss, BMI decrease, and percentage of excess weight loss (%EWL) were recorded. Wilcoxon signed rank sum test was used for paired data. Results Among 653 enrolled patients, 229 completed the 5-year follow-up. Preoperative median body weight (kg) and BMI (kg/m2) were 133.4 kg (interquartile range (IQR) = 12.0) and 48.2 kg/m2 (IQR = 10.1), respectively. Median 5-year body weight, BMI, and %EWL were 83.7 (IQR = 17.3), 31.2 (IQR = 7.7), and 74.8 (IQR = 23.4), respectively, all significantly improved compared to baseline (p = 0.002, p = 0.001, and p = 0.012, respectively). Comorbid improvement or resolution was observed in 88% of the patients. No major intraoperative complications were reported. Postoperative overall morbidity and mortality rates were 1 and 0%, respectively. Banding removal was necessary in one patient 62 months after the index operation. Conclusions The LRYGBfse seems safe and effective with durable results at 5-year follow-up. Endoscopic exploration of the gastric remnant is an additional valuable tool. Keywords Bariatric surgery . Gastric bypass . Gastric fundectomy . Ghrelin . Outcomes
* Alberto Aiolfi
[email protected]
Marco Antonio Zappa
[email protected]
Giovanni Lesti
[email protected]
1
Department of General Surgery, Fondazione Salus Clinica Di Lorenzo, Via Vittorio Veneto n 37, Avezzano, L’Aquila, Italy
Enrico Mozzi
[email protected]
2
Department of Biomedical Science for Health, Division of General and Emergency Surgery, University of Milan, Milan, Milan, Italy
3
Ezio Lattuada
[email protected]
Division of General Surgery, Istituto Auxologico Italiano – IRCCS, Milan, Milan, Italy
4
Francesco Lesti
[email protected]
Department of General Surgery, Istituto Clinico Humanitas San Pio X, Humanitas University, Milan, Milan, Italy
5
Department of General and Emergency Surgery, Ospedale Fatebenefratelli Sacra Famiglia, University of Milan, Erba, Como, Italy
Fabrizio Altorio
[email protected]
Gianluca Bonitta
[email protected]
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Introduction
Surgical Technique
The laparoscopic Roux-en-Y gastric bypass (LRYGB) is one of the most commonly worldwide-performed procedure for surgical weight loss [1]. The mechanisms leading to weight loss, diabetes improvement, and comorbid resolution are complex, still not well defined, and intensely discussed. Because of its standardization and excellent results, the LRYGB is considered by many the gold standard to properly treat morbid obesity [2, 3]. The challenging diagnosis and treatment of diseases in the gastric remnant, duodenum, and common bile duct are major limitations [4, 5]. Cancer or bleeding ulcer located in the gastric remnant are possible life-threating conditions [6–9]. Moreover, it has been shown that up to 10 and 1% of patients after RYGB may develop cholelithiasis and choledocolithiasis, respectively [10, 11]. The laparoscopic gastric bypass with fundectomy and gastric remnant exploration (LRYGBfse) was introduced in order to overcome the limitations of the LRYGB [12]. The purposes of this study were to describe the LRYGBfse surgical technique and to prospectively analyze the 5-year follow-up outcomes in a series of morbidly obese patients.
Informed consent was administered. All patients were advised to lose weight prior to the operation with a high-protein diet, which we consider essential for the reduction of the size of the left liver lobe. Preoperative antibiotic prophylaxis was given with cephalosporin (2 g) and metronidazole (500 mg). Thromboembolic prophylaxis was administered with low molecular weight heparin and pneumatic compression of the lower limbs. The operation is carried out laparoscopically using four 12-mm and one 5-mm trocars. The patient is placed in the reverse Trendelenburg position with sequential compression of the lower limbs. The operator stands between the patient’s legs and the first assistant on the left of the surgeon. Under general anesthesia, the first 12-mm trocar (ENDOPATH® Xcel ™—Ethicon Endo-Surgery, Cincinnati, OH, USA) is inserted 2 cm below the subcostal left arch slightly to the left of the mammillary line. The abdomen is insufflated at 15 mmHg and the abdominal cavity is inspected with a 30° optical view. The second 10-/12-mm trocar is placed right on the mammillary line halfway between the right subcostal arch and the transverse umbilical line. The third 10-/ 12-mm trocar is placed 2 cm above and 4 cm right of the umbilicus. The fourth 10-/12-mm optical trocar is placed in the midline 15 cm below the xyphoide process, and the fifth 5mm trocar just below the xyphoide for liver suspension. The gastrocolic ligament is opened where the right gastroepiploic vein meets the left gastroepiploic vein (Van Goethem point), with the Harmonic ACE® (Ethicon Endo-Surgery, Cincinnati, OH, USA). The ligament is opened staying close to the wall of the stomach that is prepared up to the angle of His, taking great care to seal the short vessels and to free any posterior gastric adhesions. The left pillar dissection has to be performed very meticulously and its fibers need to be visible. A hiatoplasty with one or two non-absorbable stitches could be fashioned in case of diastasis. Afterwards, a 12-mm-diameter orogastric probe is inserted and pushed up to the antrum. The gastric fundus is transected with one application of a linear 60-mm EndoGIA™ (Covidien, New Haven, CT, USA) in the direction of the reference mark located in the lesser curvature, 7 cm below the cardia. The fundectomy is completed with two or three applications of a 60-mm EndoGIA™ made vertically in the direction of the His’ angle. This allows the creation of a small gastric pouch of approximately 20–30 ml (Fig. 1a). The hepatogastric ligament is opened above the crow’s foot to enter the lesser sac taking care to preserve the neural (Latarjet nerve) and vascular structures. All the posterior adhesions between the stomach and the pancreas should be carefully divided. A curved forceps is then inserted from the left side, below the gastric pouch, and the ePTFE banding is gripped. The two ends of the banding
Methods From January 2008 to December 2015, 653 consecutive patients underwent the laparoscopic gastric bypass with fundectomy and were prospectively followed during a 5year period. Previous open abdominal surgery was an exclusion criterion. Four third-level centers participated in the study and IRB approval was obtained in each institution. Four surgeons experienced in bariatric surgery (GL, EM, EL, MZ) performed the operations. Follow-up visits were scheduled at 10 days, 1, 3, 6, and 12 months, annually, or whenever necessary. For the purposes of this study, the comorbidities were considered resolved if the patients required no medication and had normal blood test results during follow-up. The comorbidities were considered improved if patients required less medication or had improved blood test results.
Preoperative Evaluation All patients were selected according to the criteria for bariatric surgery proposed by the National Institutes of Health (NIH) Consensus of 1991 and updated by the Italian Society of Obesity Surgery (SICOB). Patients eligible for bariatric surgery (BMI > 35 kg/m2) with obesity-related comorbidities underwent evaluation of a specialized multidisciplinary team. Preoperative tests were lipid profile, chest X-ray, cardiological assessment, spirometry with blood gas analysis, dietician evaluation, psychological eating behavior appraisal, gastroscopy with biopsy to rule out Helicobacter pylori, and abdominal ultrasound.
OBES SURG Fig. 1 a The gastric fundectomy is performed with a linear laparoscopic stapler (EndoGIA™). The fundus is transected creating a small gastric pouch of approximately 20–30 ml. b The polytetrafluorethylene banding (ePTFE) is placed 7 cm below the cardia and fixed with an unabsorbable braided wire to gently close the outlet from the gastric pouch, diverting the bolus toward the gastrojejunal anastomosis
are gently pulled and closed around the gastric pouch and Bougie (opening circumference, OC). Afterwards, the Bougie is removed and the banding is pulled in order to gently close the gastrogastric communication (internal circumference, IC), which is about 15 mm less than the OC. The banding is closed with an unabsorbable suture or EndoGIA™ (Fig. 1b). The jejunum is divided 150 cm distal to the ligament of Treitz and a linear side-to-side gastrojejunal anastomosis (30-mm EndoGIA™) is fashioned, on the posterolateral wall of the gastric pouch, 5 cm below the cardia. The bypass is then completed with a linear side-to-side jejunojejunal anastomosis (150-cm antecolic Roux limb) with a common channel of at least 300 cm (Fig. 2). Enterotomies are closed with interrupted absorbable sutures (Vicryl 4/0®). The omega loop is cut near the pouch and the stapler line is oversewn. An intraoperative methylene blue dye test is performed to rule out early leaks. The gastrojejunal anastomosis is wrapped with an omental flap protection. An abdominal silicone drain is placed under the wrapped anastomosis. The gastric fundus is placed in the endobag and removed.
Fig. 2 a The laparoscopic gastric bypass with fundectomy and gastric remnant exploration (LRYGBfse) technique. The jejunum is divided 150 cm distal to the ligament of Treitz. The bypass is completed with a 150cm antecolic Roux limb with a common channel of at least 300 cm. b The side-to-side gastrojejunal anastomosis is fashioned on the posterolateral wall of the gastric pouch, 5 cm below the cardia (box)
Prophylactic cholecystectomy was not performed if there was no evidence of stones or sludge in the gallbladder. On the first postoperative day, all the patients underwent a Gastrografin swallow study to exclude leaks and to investigate the shape of the pouch. If no leak was detected, the patient was allowed to resume a clear liquid diet and discharged home on the fourth postoperative day on a sloppy diet. Patients receive a standardized diet allowing soft food for 4 weeks. A solid diet is allowed after 1 month. Omeprazole (40 mg) was given until the 30th postoperative day and oral vitamin support was introduced. An endoscopic evaluation was systematically performed in all patients every year after the operation or whenever necessary (Fig. 3a).
Statistical Analysis Continuous data are presented as median and range or interquartile range (IQR). Categorical variables are shown as absolute frequencies and percentage. Wilcoxon signed rank sum test was performed for paired data. Confidence intervals at
OBES SURG Fig. 3 a Endoscopic view: the gastrogastric anastomosis (black arrow) is gently closed with the polytetrafluorethylene (ePTFE) banding to divert the bolus toward the gastrojejunal anastomosis. b Gastrografin swallow study: all of the contrast passes through the gastrojejunal anastomosis
95% were computed using normal approximation or rule of three as appropriate [13]. Two-tail statistical tests were performed and p value equal to or lower than 0.05 was considered significant. All statistical analyses were carried out using R version 3.2.2 software [14].
Results A total of 653 obese patients underwent LRYGBfse as a primary bariatric procedure. The preoperative characteristics of the patient population are reported in Table 1. The median age was 43.4 years old (range 24–63), 405 were females (62%), and the preoperative median BMI was 48.2 (range 34–56.6). Overall, 466 patients (71.4%) had a BMI > 40 and < 50 kg/m2. Comorbidities were hypertension requiring medications (49.5%), dyslipidemia (47.3%), gastroesophageal reflux
Table 1 Preoperative demographics and clinical characteristics of patients’ population No. of patients Age, years, median (range) Females, n (%) Preop body weight, kg, median (range) Preop BMI, kg/m2, median (range) BMI 35–< 40 kg/m2, n (%) BMI 40–< 50 kg/m2, n (%) BMI 50–< 60 kg/m2, n (%) Comorbidities Hypertension, n (%) Dyslipidemia, n (%) Gastroesophageal reflux disease (GERD), n (%) Diabetes, n (%) OSAS, n (%) Depression, n (%) OSAS obstructive sleep apnea syndrome
653 43.4 (24–63) 405 (62) 133.4 (87–162) 48.2 (34–56.6) 62 (9.5) 466 (71.4) 125 (19.1) 323 (49.5) 309 (47.3) 245 (37.6) 161 (24.6) 127 (19.4) 114 (17.5)
disease under PPI (37.6%), type 2 diabetes requiring insulin therapy or oral hypoglycemic agents (24.6%), obstruction sleep apnea syndrome (OSAS) (19.4%), and depression (17.5%) (Table 1). The median operative time was 155 min (range 108–227). The median length of the ePTFE band was 56 mm (range 52– 64). In 105 patients (16%), a hiatoplasty with one or two interrupted sutures was fashioned because of the presence of hiatal hernia. Cholecystectomy was concomitantly performed in 38 patients (5.8%). No major intraoperative complications were observed, intraoperative blood loss was negligible, and no laparotomy conversion was required. The overall procedure-related morbidity rate was 1.1% (95% CI 0.4–2.3%). In two patients, the postoperative course was complicated by gastric anastomosis bleeding successfully managed with endoscopic clipping. In another patient, a significant intra-abdominal bleeding occurred and an emergent laparotomy was performed without finding the source of bleeding. In two cases, a postincisional trocar site hernia required a laparoscopic revision, respectively, in the 8th and 61st postoperative days. In two other cases, a small bowel intestinal occlusion related to an internal hernia required a laparoscopic revision 7 and 174 days after the index operation. No anastomotic leak, venous thromboembolism, pulmonary complications, or surgical site infections were observed. The median postoperative in-hospital length of stay was 4 days (range 2–10) and median ICU length of stay was 1 (range 1–2). None of the patients required postoperative mechanical ventilator assistance. The overall mortality was 0% (95% CI 0.0–0.4%). Compliance to 1-year follow-up was 100%. Overall, 371 patients (57%) completed the 3-year follow-up, and 229 patients (35%) ended the 5-year follow-up. The median postoperative body weight, BMI, and percentage of excess weight loss (%EWL) are reported in Table 2. The median 5-year BMI and %EWL were significantly improved compared to baseline (p = 0.001 and p = 0.012, respectively). At 5-year follow-up, comorbid improvement or resolution was observed in 88% of
OBES SURG Table 2
Body weight (kg), body mass index (BMI), and percentage of excess weight loss (%EWL) at different follow-ups
Variables
Preop
1 year. (n = 653)
2 years (n = 520)
3 years (n = 371)
5 years (n = 229)
Weight, kg, median (range)
133.4 (12.0) 48.2 (10.1)
83.2 (15.3) 29.8 (3.9)
81.3 (16.9) 28.2 (2.6)
81.7 (15.7) 30.5 (8.4)
83.7 (17.3) 31.2 (7.7)
–
74.2 (23.5)
77.2 (21.6)
76.4 (21.9)
74.8 (23.4)
BMI, kg/m2, median (range) %EWL, median (range)
patients (Table 3). No functional stenosis or dysphagia were recorded. In a subset of 25 patients, pre- and postoperative (6 months) ghrelin levels were measured and compared. A significant decrease of the mean ghrelin serum concentration was recorded (725 vs. 386 pg/ml, p < 0.05). Endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy was necessary in two patients for symptomatic choledocolithiasis at 28 and 35 months respectively after the index operation. The procedure was uneventful without complications. In another patient, a prepyloric cancer was endoscopically diagnosed 15 months after the LRYGBfse because of persistent epigastric pain and excessive weight loss. A subtotal gastrectomy with D2 lymphadenectomy was performed. Laparoscopic banding removal was necessary in one patient 62 months after the LRYGBfse. A 26-year-old smoker pregnant female developed hematemesis from a marginal ulcer. Because of pregnancy, the patient could not assume PPI and the decision to remove the ePTFE banding was taken. No evidence of full-thickness erosion was found intraoperatively. The operative time was 45 min and no complications occurred in the postoperative course. The patient gave birth to a 4012 g baby 4 months after the operation. Two other female patients gave birth to a baby 24 and 38 months after the operation.
Discussion LRYGB was first described by Wittgrove et al. in 1994 [15]. Over the ensuing decades, the surgical technique as well as the perioperative care of patients had been improved and refined [16]. Nowadays, the LRYGB is the gold standard treatment and one of the most commonly performed operation for morbid obesity worldwide [1]. However, in areas with a high
Table 3 Comorbid resolution or improvement in the patient population at 5-year follow-up
incidence of gastric cancer, such as northern Asia and Japan, the development of gastric cancer in the excluded, nonscreenable stomach is a matter of concern [17, 18]. It is true that the incidence of gastric cancer is very high in Japan, but not negligible in other countries. In addition, potential lifethreatening conditions including perforation and bleeding ulcer located in gastric remnant have been described [7–9]. The challenging endoscopic access to the excluded stomach and pancreaticobiliary system represent a major limitation of the LRYGB. Some techniques have been described in order to overcome this limitation such as single-/double-balloon enteroscopy and laparo-endoscopic transgastric approaches [19–23]. However, these techniques are expensive, time consuming, and not easily performed as a screening tool in asymptomatic patients [17, 18]. In addition, the incidence of cholelithiasis and choledocolithiasis has been reported to be not negligible after LRYGB while prophylactic cholecystectomy is still largely debated in the surgical community [10, 11, 24–26]. In an attempt to overcome these limitations, we proposed the LRYGBfse. The described LRYGBfse technique has been developed from 2002 to January 2008. The first idea was to create an adjustable 2-cm communication between the gastric pouch and the gastric remnant in order to easily explore the residual stomach without affecting the outcomes. In order to calibrate the gastrogastric communication, an adjustable silicone banding was initially used. Overall, 52 patients underwent this modified gastric bypass, but because of the high migration rate (7/52; 13.5%), the technique was abandoned. From January 2008, the silicone gastric banding was replaced with a more flexible and adaptable polytetrafluorethylene band (ePTFE) (1 mm thick, 0.8 cm wide, and 5–7 cm long). With the use of the ePTFE banding,
Hypertension, n (%) Dyslipidemia, n (%) Gastroesophageal reflux disease (GERD), n (%) Diabetes, n (%) OSAS, n (%) Arthritis, n (%) OSAS obstructive sleep apnea syndrome
Resolution
Improvement
No change
89 (67.4) 89 (75.3) 82 (84.8) 46 (68.5) 32 (60.5) –
35 (26.1) 29 (24.7) 15 (15.2) 14 (21.4) 21 (39.5) 26 (100)
8 (6.5) – – 7 (10.1) – –
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no episodes of migration were observed. The creation of a gastrogastric virtual communication is the result of a specific, well-calibrated surgical procedure that is different from the pathologic gastrogastric fistula. The gastrogastric fistula is a rare (1–2%) and well-reported complication after LRYGP that may affect outcomes [27]. Staple line ischemia, necrosis, inflammatory processes, marginal ulcers, and increased intraluminal pouch pressure are all possible determining factors [28]. In addition, the location and the clinical expression are extremely dissimilar being the gastrogastric fistula proximal to the gastrojejunal anastomosis and usually associated with a lack of satiety and failed weight loss. The second idea was the resection of the gastric fundus for physiological and technical reasons. The resection of the gastric fundus determines a significant decrease in the secretion of ghrelin, a hormone produced almost exclusively by the gastric fundus. The ghrelin effects on body weight and its impact on glucose homeostasis and appetite are well known [29–31]. In our study, a significant decrease of serum ghrelin concentration was found in a small subgroup of 25 patients. The serum ghrelin concentration was measured 180 days after the index operation in order to avoid any possible confounders related to the early postoperative phase of rapid weight loss. Geloneze et al. claimed that ghrelin suppression is a key factor in the complex mechanism of weight loss after RYGP. The authors argued that the location of the resection line, whether it excluded more or less of the gastric fundus, determined the total amount of postoperative ghrelin suppression with consequent appetite suppression [32]. Chronaiou et al. evaluated the effect of the fundus resection (FR) in patients undergoing standard LRYGB. Fasting ghrelin decreased at 3 months after LRYGB, but increased at 12 months to above baseline, while after LRYGB with fundus resection, it decreased markedly and persistently. Postprandial GLP-1, PYY, and insulin response were further enhanced and postprandial glucose levels were lower after LRYGBFR compared to those after LRYGB. Body weight and body mass index decreased markedly and comparably after both procedures. Interestingly, the fundus resection enhances the efficacy of the procedure in term of weight loss, fasting glucose levels, and hormonal secretions. The authors conclude that the resection of the gastric fundus in patients undergoing LRYGB was associated with persistently lower fasting ghrelin levels, higher postprandial PYY, GLP-1, and insulin responses, and lower postprandial glucose levels compared to standard LRYGB [33]. These findings suggest that the fundus resection with concomitant ghrelin suppression could be an effective adjunct in the treatment of morbid obesity and type 2 diabetes. It has been shown that the use of a linear stapler for the side-to-side gastrojejunal anastomosis seems to be superior compared to the circular stapler in terms of short-term complications, operative time, procedure costs, and anastomotic strictures with no differences in terms of leakage and weight
loss [34, 35]. As documented by the Gastrografin swallow study, a complete functional duodenal exclusion is achieved with all the radiopaque bolus rapidly diverted through the gastrojejunal anastomosis (Fig. 3b). Akkary and colleagues sustained that prompt emptying of the gastric pouch predicts improved weight loss because prompt and rapid arrival of bolus in the foregut and hindgut results in an increased GLP-1 and PYY hormone secretion [36]. A durable effect of the LRYGBfse was found at the 5-year follow-up. Compared to baseline, a significant improvement of body weight, BMI, and EWL% were recorded. A significant comorbid improvement or resolution was observed in the majority of the patients. These results could be explained by a complex combination of restrictive, malabsorptive, and hormonal mechanisms. Moreover, foregut and hindgut theories may explain the improvement in diabetes and weight loss [37]. Concerns may be related to possible banding migration, slippage, or erosion. No band erosion or dislocation was observed in the patient population. One possible explanation could be the presence of a small amount of lesser sac between the ePTFE banding and the gastric wall thus avoiding a direct contact. However, in one heavy-smoker patient, removal of the banding was necessary because of development of marginal ulcer and bleeding. This is in accordance with Cariani and colleagues that reported a 0.7% incidence of marginal ulcer at a 4-year follow-up [38]. We believe that, adequate PPI therapy, smoke suspension, and endoscopic surveillance in case of symptoms are mandatory to prevent such complications. The opportunity to perform diagnostic and therapeutic endoscopic procedures for any disease of the stomach, duodenum, and common bile duct is a major strength of the LRYGBfse. In all the patients, an endoscopic exploration of the gastric remnant was systematically performed during follow-up. Interestingly, we never found biliary traces in the stomach. This is probably explained by the preserved gastric motility due to the integrity of the Latarjet nerve and the length of the biliary limb (150 cm). This is an essential finding, thus revealing no bile reflux in the gastric pouch and remnant. Endoscopy was therapeutically essential in three patients (1.3%) during follow-up. This should be a critical point of discussion whenever considering the increasing number of LRYGB performed each year worldwide in a population of young patients that will probably need a screening gastroscopy in the future. Selection bias could be not be excluded but is slightly controlled by the prospective multicenter nature of the study. In addition, the occurrence of banding erosion, dislocation, infection, and stenosis, development of marginal ulcer, and clinical outcomes should be further analyzed in the long-term follow-up. A limitation of the LRYGBfse could be the lack of standardization regarding the precise force that should be
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applied to close the ePTFE banding in order to gently close the inner circumference. The development of a new adjustable dual-component banding (European patent no. 3030202) that combines the elasticity of silicone and the tissue compatibility of ePTFE could be a valid option. A multicenter prospective study will be conducted with this new dual-component banding in order analyze the safety and effectiveness of this new device.
6.
7.
8.
9.
Conclusions 10.
The gastric bypass with fundectomy and gastric remnant exploration is feasible and effective in the medium-term followup when considering weight loss and comorbid resolution. Major advantage of the technique is the easy exploration of the excluded stomach and access to the Vater’s papilla. The gastric bypass with fundectomy seems to be a valid alternative to the standard LRYGB. A randomized control trial is advisable in order to validate these findings. Acknowledgements The authors thank Maria Tosetti for her help with graphics and figures.
11.
12.
13. 14.
Author Contribution G.L., A.A, F.L., and M.Z. did the literature search. G.L., A.A., and M.Z. formed the study design. Data collection was done by G.L., A.A., E.M., F.A., E.L., and M.Z. G.L., A.A., and G.B. analyzed the data. G.L., A.A., and M.Z. interpreted the data.
15.
16.
Compliance with Ethical Standards All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
17.
18. Conflict of Interest The authors declare that they have no conflict of interest. Informed Consent Informed consent was obtained from all individual participants included in the study.
19.
References
20.
1. 2. 3. 4.
5.
Angrisani L, Santonicola A, Iovino P, et al. Bariatric surgery worldwide 2013. Obes Surg. 2015 Oct;25(10):1822–32. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292:1724–37. Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013;23:427–36. Grimes KL, Maciel VH, Mata W, et al. Complications of laparoscopic transgastric ERCP in patients with Roux-en-Y gastric bypass. Surg Endosc. 2015 Jul;29(7):1753–9. Frederiksen NA, Tveskov L, Helgstrand F, et al. Treatment of common bile duct stones in gastric bypass patients with laparoscopic
21.
22.
23.
transgastric endoscopic retrograde cholangiopancreatography. Obes Surg. 2017 Jun;27(6):1409–13. Papasavas PK, Yeaney WW, Caushaj PF, et al. Perforation in the bypassed stomach following laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2003 Oct;13(5):797–9. Gypen BJ, Hubens GJ, Hartman V, et al. Perforated duodenal ulcer after laparoscopic gastric bypass. Obes Surg. 2008 Dec;18(12): 1644–6. Harper JL, Beech D, Tichansky DS, et al. Cancer in the bypassed stomach presenting early after gastric bypass. Obes Surg. 2007 Sep;17(9):1268–71. Orlando G, Pilone V, Vitiello A, et al. Gastric cancer following bariatric surgery: a review. Surg Laparosc Endosc Percutan Tech. 2014 Oct;24(5):400–5. Mishra T, Lakshmi KK, Peddi KK. Prevalence of cholelithiasis and choledocholithiasis in morbidly obese south Indian patients and the further development of biliary calculus disease after sleeve gastrectomy, gastric bypass and mini gastric bypass. Obes Surg. 2016;26: 2411–7. Navaratne L, Baltar J, Bustamante M, et al. Treatment of common bile duct stones in gastric bypass patients with laparoscopic transgastric endoscopic retrograde cholangiopancreatography. Obes Surg. 2017 Oct;27(10):2675–6. Zappa MA, Aiolfi A, Musolino C, et al. Vertical gastric bypass with fundectomy: feasibility and 2-year follow-up in a series of morbidly obese patients. Obes Surg. 2017 Aug;27(8):2145–50. Simonoff JS. Analyzing categorical data. New York, NY: Springer; 2003. R Core Team. R: a language and environment for statistical computing. R Foundation for Statistical Computing [cited 2016 Mar 14]. Available from: www.r-project.org. Wittgrove AC, Clark GW, Tremblay LJ. Laparoscopic gastric bypass, Roux-en-Y: preliminary report of five cases. Obes Surg. 1994 Nov;4(4):353–7. Lehman Center Weight Lo ss Surg ery Expert Panel. Commonwealth of Massachusetts Betsy Lehman Center for Patient Safety and Medical Error Reduction Expert Panel on Weight Loss Surgery: executive report. Obes Res. 2005 Feb;13(2):205–26. Kasama K, Tagaya N, Kanehira E, et al. Laparoscopic sleeve gastrectomy with duodenojejunal bypass: technique and preliminary results. Obes Surg. 2009 Oct;19(10):1341–5. Naitoh T, Kasama K, Seki Y, et al. Efficacy of sleeve gastrectomy with duodenal-jejunal bypass for the treatment of obese severe diabetes patients in Japan: a retrospective multicenter study. Obes Surg. 2017 Aug 9; https://doi.org/10.1007/s11695-017-2874-4. [Epub ahead of print]. Schreiner MA, Chang L, Gluck M, et al. Laparoscopy-assisted versus balloon enteroscopy-assisted ERCP in bariatric post-Rouxen-Y gastric bypass patients. Gastrointest Endosc. 2012 Apr;75(4): 748–56. Abu Dayyeh B. Single-balloon enteroscopy-assisted ERCP in patients with surgically altered GI anatomy: getting there. Gastrointest Endosc. 2015;82(1):20–3. Shah RJ, Smolkin M, Yen R, et al. A multicenter, U.S. experience of single-balloon, double balloon, and rotational overtube-assisted enteroscopy ERCP in patients with surgically altered pancreaticobiliary anatomy (with video). Gastrointest Endosc. 2013;77:593–600. Saleem A, Baron TH, Gostout CJ, et al. Endoscopic retrograde cholangiopancreatography using a single-balloon enteroscope in patients with altered Roux-en-Y anatomy. Endoscopy. 2010;42: 656–60. Abbas AM, Strong AT, Diehl DL, et al. Multicenter evaluation of the clinical utility of laparoscopy-assisted ERCP in patients with
OBES SURG Roux-en-Y gastric bypass. Gastrointest Endosc. 2017 Nov 9. pii: S0016–5107(17)32443–4. 24. Wanjura V, Szabo E, Österberg J, et al. Morbidity of cholecystectomy and gastric bypass in a national database. Br J Surg. 2018 Jan;105(1):121–7. 25. Bastouly M, Arasaki CH, Ferreira JB, et al. Early changes in postprandial gallbladder emptying in morbidly obese patients undergoing Roux-en-Y gastric bypass: correlation with the occurrence of biliary sludge and gallstones. Obes Surg. 2009;19:22–8. 26. Shiffman ML, Sugerman HJ, Kellum JM, et al. Gallstone formation after rapid weight loss: a prospective study in patients undergoing gastric bypass surgery for treatment of morbid obesity. Am J Gastroenterol. 1991 Aug;86(8):1000–5. 27. Ribeiro-Parenti L, De Courville G, Daikha A, et al. Classification, surgical management and outcomes of patients with gastrogastric fistula after Roux-En-Y gastric bypass. Surg Obes Relat Dis. 2017 Feb;13(2):243–8. 28. Carrodeguas L, Szomstein S, Soto F, et al. Management of gastrogastric fistulas after divided Roux-en-Y gastric bypass surgery for morbid obesity: analysis of 1,292 consecutive patients and review of literature. Surg Obes Relat Dis. 2005 Sep-Oct;1(5):467–74. 29. Le Roux CW, Aylwin SJB, Batterham RL, et al. Gut hormone profiles following bariatric surgery for an anorectic state, facilitate weight loss and improve metabolic parameters. Ann Surg. 2006;243:108–14. 30. Christou NV, Look D, Maclean LD. Pre-and post-prandial ghrelin levels do not related with satiety or failure to achieve a successful outcome after Roux-en-Y gastric bypass. Obes Surg. 2005;15: 1017–23. 31. Korner J, Bessler M, Cirilo LJ, et al. Effects of gastric Roux-en-Y bypass surgery on fasting and postprandial concentrations of
32.
33.
34.
35.
36.
37.
38.
ghrelin, peptideYY, and insulin. J Clin Endocrinol Metab. 2005;90:359–65. Geloneze B, Tambascia MA, Pilla VF, et al. Ghrelin: a gut-brain hormone: effect of gastric bypass surgery. Obes Surg. 2003 Feb;13(1):17–22. Chronaiou A, Tsoli M, Kehagias I, et al. Lower ghrelin levels and exaggerated postprandial peptide-YY, glucagon-like peptide-1, and insulin responses, after gastric fundus resection, in patients undergoing Roux-en-Y gastric bypass: a randomized clinical trial. Obes Surg. 2012 Nov;22(11):1761–70. Langer FB, Prager G, Poglitsch M, et al. Weight loss and weight regain-5-year follow-up for circular- vs. linear-stapled gastrojejunostomy in laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2013 Jun;23(6):776–81. Giordano S, Salminen P, Biancari F, et al. Linear stapler technique may be safer than circular in gastrojejunal anastomosis for laparoscopic Roux-en-Y gastric bypass: a meta-analysis of comparative studies. Obes Surg. 2011 Dec;21(12):1958–64. Akkary E, Sidani S, Boonsiri J, et al. The paradox of the pouch: prompt emptying predicts improved weight loss after laparoscopic Roux-Y gastric bypass. Surg Endosc. 2009 Apr;23(4):790–4. Rubino F, Schauer PR, Kaplan LM, et al. Metabolic surgery to treat type 2 diabetes: clinical outcomes and mechanisms of action. Annu Rev Med. 2010;61:393–411. Cariani S, Palandri P, Della Valle E, et al. Italian multicenter experience of Roux-en-Y gastric bypass on vertical banded gastroplasty: four-year results of effective and safe innovative procedure enabling traditional endoscopic and radiographic study of bypassed stomach and biliary tract. Surg Obes Relat Dis. 2008 Jan-Feb;4(1): 16–25.
