Fissurectomy combined with anoplasty and injection of ... - Springer Link

Tech Coloproctol (2010) 14:31–36 DOI 10.1007/s10151-009-0562-7

ORIGINAL ARTICLE

Fissurectomy combined with anoplasty and injection of botulinum toxin in treatment of anterior chronic anal fissure with hypertonia of internal anal sphincter: a pilot study R. Patti • F. Fama` • A. Tornambe` • G. Asaro G. Di Vita

•

Received: 16 July 2009 / Accepted: 21 December 2009 / Published online: 3 February 2010 Ó Springer-Verlag 2010

Abstract Background In patients affected by anterior chronic anal fissure (CAAF) with hypertonia of the internal anal sphincter (IAS), the role of IAS hypertonia remains unclear. The aim of this study was to evaluate the efficacy of fissurectomy combined with advancement flap and IAS injection of botulinum toxin in healing the CAAF with hypertonia of IAS resistant to medical therapy. Methods Ten consecutive patients were enrolled. Anorectal manometry was performed preoperatively and at 6 months. CAAF with hypertonia was defined as those associated with maximum resting pressure (MRP) values higher than 85 mmHg. All patients underwent fissurectomy and anoplasty with advancement skin flap combined with the intrasphincter injection of 30 UI of botulinum toxin. Complete healing, MRP changes, relief of symptoms and immediate and long-term complications were recorded. Results Complete healing was observed in all patients within 30 days of the operation. The intensity and duration of pain post-defecation was reduced significantly starting from the first defecation. In all subjects, the preoperative MRP values were significantly reduced at 6 months. One month after surgery, three patients reported anal incontinence, two of them had complained preoperatively. The only postoperative complications were minor. Conclusions Fissurectomy combined with advancement flap and intrasphincter injection of botulinum toxin results in complete healing, significant MRP reduction and full

R. Patti F. Fama` A. Tornambe` G. Asaro G. Di Vita (&) Department of Surgical and Oncological Science, Division of General Surgery, University of Palermo, Via Liborio Giuffre` no 5, Palermo, Italy e-mail: [email protected]

relief of symptom in all patients, thus it represents a valid procedure in preventing the occurrence of anal incontinence. Keywords Anterior chronic anal fissure Fissurectomy Advancement flap Botulinum toxin

Introduction It has been estimated that chronic anal fissure (CAF) afflicts about 10% of the patients who come to colorectal clinics, with both sexes affected equally [1, 2]. The majority of CAF occurs in the posterior midline of the anal canal, they are located in the anterior midline (CAAF) with low frequency, and rarely are double or in the lateral walls [3]. First line treatment of CAF is pharmacological. Some studies [4, 5] indicate that in patients with CAAF who had been resistant to medical treatment, two profiles can be distinguished according to their maximum resting pressure (MRP) values; the profile that is more numerous includes patients with MRP values that are within normal limits, the second profile comprises subjects with MRP values above normal. The lateral internal sphincterotomy is considered by many authors the treatment of choice for CAF after the failure of conservative therapy. A recent systematic review of randomized surgical trials identified an overall risk of incontinence of 10% mostly for flatus [6]. In the patients affected by CAAF with hypertonia of IAS, the unclear role of IAS hypertonia in their pathogenesis, and considering the normal weakening of the sphincter with age and the possibility of future anorectal surgery, radiation or obstetrical trauma, lateral internal sphincterotomy appears inopportune.

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The fissurectomy is the procedure most used to preserve the anatomo-functional integrity of the anal sphincters. However, the possible complication of keyhole defect that may lead to faecal soiling limits its use [7]. In order to allow rapid healing of the residual wound following fissurectomy and to reduce the incidence of complications, advancement flaps have been used with good results. The aim of this study was to evaluate the efficacy of fissurectomy and the modifications of the tone of the IAS with advancement flap through healthy skin associated with the intrasphincter injection of botulinum toxin in a cohort of patients affected by CAAF with hypertonia of IAS resistant to medical treatment.

Methods Ten consecutive patients affected by CAAF with hypertonia of IAS unresponsive to medical therapy and who refused further medical treatment were enrolled in this prospective study from January 2002 to January 2008. All subjects gave written informed consent, and the local ethics committee approved the study. Exclusion criteria were the presence of multiple fissures, fistulas in ano, syphilis, inflammatory bowel disease, anal abscess or malignant disease. CAAF resistant to medical treatment was defined as those that fail to heal after topical medical therapy and high-fibre dietary supplementation. Preoperative anorectal manometry was performed at least 4 weeks after cessation of glyceril trinitrate ointment or calcium channel blocker therapy at 15 weeks after toxin botulinum injection. A manometric control was repeated 6 months after surgery. The manometry was carried out by a manometric sensor (2.1 mm external diameter) with four circle orifices and with a latex micro-balloon at its extremity (Marquat C87, Boissy, St-Leger, France). The machine was connected to a polygraph (Narco, Byo-System MMS 200, Houston, TX, USA), using the station pull-through method with perfusion of normal saline and the patient was lying in the right lateral position. On the manometry, MRP was defined as maximum pressure detected on resting. Data collected by our anorectal pathophysiology laboratory, according to others [8], showed that normal range MRP values were from 45 to 85 mmHg. CAAF with hypertonia was defined as those whose MRP values were higher than 85 mmHg [8]. All patients underwent fissurectomy in the gynaecological position under spinal anaesthesia. An Eisenhammer anal speculum was gently inserted into the anal canal, taking care to avoid sphincter dilation. After injection of 5 ml of local anaesthetic solution (100 mg cloridrate mepivacain and 0.025 mg L-adrenaline), the fibrotic edges were excised with a scalpel until normal non-fibrotic anodermal tissue showed sufficient bleeding. The sentinel skin

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Tech Coloproctol (2010) 14:31–36

tag and hypertrophied papilla at the level of dentate line were excised when present according to Gupta et Kalaskar [9]. The tissue at the base of the fissure was curetted until there were clean muscle fibres of the IAS. There was no use of diathermy and careful attention was given not to damage the IAS. Standard advancement anoplasty was performed using a flap of healthy skin tissue which was mobilized and then advanced with its blood supply to fill the defect. The flap was secured without tension to the anal canal and the skin was closed tension free in a V–Y manner behind the advanced flap (Fig. 1). Once the fissurectomy and the anoplasty was performed, the botulinum toxin A (Botox, Allergan, Westport, Ireland) stored at -20°C and diluted in saline to 50 UI/ml was injected into IAS with a 27-gauge needle. Each patient received a total of 30 UI of botulinum toxin equally divided on either side of the posterior midline. According to others [10], we always performed a Botox injection posteriorly because the site of injection depends on the location of the fissure and it should be anterior for posterior fissure and posterior for anterior ones [10]. None of the patients assumed concomitant oral medications that could interfere with the action of type A botulinum toxin (aminoglycosides, baclofen, dantrolene, diazepam) and there was no known hypersensitivity to any component of botulinum toxin formulation. All procedures were carried out by the same senior surgeon. Before surgery, all patients received a small volume of phosphatesaline enema. Metronidazole was administered intravenously in a dose of 500 mg 1 h before surgery. Subsequently, it was administered per os at the dosage of 250 mg for 7 days, three times daily. During the first 2 weeks after the operation, patients took variable doses of psyllium fibre. A laxative preparation (sennosides) was given orally to subjects who had not yet passed stools 3 days after surgery. Enema, suppositories and all rectal manipulations were avoided. Immediately after surgery, all patients received 100 mg of diclofenac intramuscularly for analgesia and were instructed to take only 100 mg nimesulide tablets as required. The primary goal was the patient’s complete healing and MRP changes of the anal sphincter; the secondary goal included symptom relief (bleeding, pain, pruritus) and the immediate and long-time complications (incontinence, anal stenosis, keyhole deformity, urinary retention, related side effects of botulinum toxin) that were recorded pro forma. A complete healing was defined as a complete epithelialization of the advancement skin flap. Both duration and intensity of pain post-defecation were evaluated. Pain intensity was scored with a visual analogical scale (VAS) from 0 to 10, where 0 corresponded to no pain and 10 to the worse pain conceivable [11]. Anal incontinence was assessed preoperatively and after 1, 6 and 12 months from the surgical operation using the Pescatori grading system: A, incontinence for flatus and mucus; B,


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liquid stool; C, solid stool; and 1 for occasional, 2 for weekly and 3 for daily [12]. Patients were as outpatients discharged 24–48 h after surgery, afterwards they were examined until they were completely healed and they were also checked at 1, 6 and 12 months following the surgical operation. Independently of these scheduled appointments, patients were seen on request.

trinitrate alone. Two patients had previously failed only botulinum toxin therapy at the dosage of 40 UI. Among the remaining 4 patients, after failure of glycerin trinitrate, two were treated with injection of 40 UI botulinum toxin into the anal sphincter and two patients had a past topical calcium channel blocker. The clinical characteristics of patients are reported in Table 1.

Statistical analysis

Healing fissure and relief of symptoms

Continuous variables were expressed as a mean with standard deviation and qualitative data as absolute frequencies, MRP values were also given as median and range. Student’s t-test with Welch correction was used to analyse the differences of pain score and pain duration at each registration point. Values of P \ 0.05 were considered statistically significant.

All patients healed completely within 30 days from operation. The intensity and the duration of pain post-defecation was reduced significantly compared to the preoperative values starting from the first defecation (P \ 0.0001 and P \ 0.0001, respectively) (Table 2). None of the patients complained of pain, bleeding or pruritus 30 days after surgery. Analgesic use decreased significantly after the 1st defecation (data not shown).

Results Baseline characteristics of patients The patients included were 7 women and 3 men with a median age of 37 years (range 18–56). Bowel habits were normal in 3 patients and constipation was detected in 7 subjects in accordance with up-dated Rome diagnostic criteria previously available [13]. Two women were nullipare, whereas three had given birth vaginally, one time or more, and in all cases an episiotomy was performed and two had caesarean delivery. Fissure characteristics The mean duration of symptoms was 9.5 ± 6.8 months. Four patients failed a therapeutic course of glycerin

MRP and anal continence Preoperatively, the MRP values were a median of 99 mmHg with a range of 88 to 120. At 6 months revision, MRP values were a median of 79.5 mmHg with a range of 68 to 98 mmHg. Comparing these values , a significant difference (P \ 0.001) was recorded. In particular, in all patients, the preoperative value of MRP was lower at 6 months of surgery and the overall reduction was 20.5% (Fig. 2). Preoperatively, two patients reported anal incontinence, in both cases classified as A2 according to the Pescatori grading system. One month after surgery, anal incontinence was reported in three patients, two of whom had complained preoperatively; in particular, one patient was classified as A1, two were classified as A2. At 6 months, only two patients reported incontinence, whereas at 12 months, only one patient had incontinence that was classified as A2. Table 1 Clinical characteristics of CAAF No

%

Gender M

3

30

F

7

70

Hypertrophied anal papilla

8

80

Skin tags

7

70

Pain Bleeding

10 7

100 70

Pruritus

5

50

Symptoms

Duration of symptoms Fig. 1 The flap is secured without tension to the anal canal and the skin is closed tension free in a V–Y manner behind the advanced flap

Months (mean ± SD)

9.5 ± 6.8

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Table 2 Intensity of pain evaluated by VAS and duration of pain expressed in minutes after defecations Pain Intensity

Duration

Preoperative

7.9 (1.3)

136.3 (18.1)

1st defecation

3.3 (1.1)*

29.5 (15.3)**

3rd defecation 5th defecation

2.4 (0.9) 1.5 (0.6)

17.5 (13.4) 10.2 (6.8)

7th defecation

0.8 (0.3)

8.3 (4.7)

9th defecation

0.4 (0.3)

4.5 (1.9)

12th defecation

0.2 (0.2)

4.1 (0.8)

Values are expressed as mean and (SD). Student’s t test with Welch correction was used to compare the difference between each point Significance: 1st ** P \ 0.0001

defecation

vs.

preoperative

* P \ 0.0001;

Complications and follow-up There were no cases of urinary retention, anal stenosis or keyhole deformity. No necrosis of the transposed flap was observed. The only complications recorded postoperatively were of slight entity and in no case required further surgery; in particular, two infections were detected in the donor site and a partial break down occurred in one case. At 12 months follow-up, no recurrences were recorded and in no case was further surgery necessary.

Discussion This study suggests that fissurectomy in combination with advancement flap and intrasphincter injection of 30 UI of botulinum toxin in patients with CAAF with hypertonia of IAS and resistant to medical therapy results in as high a healing rate without affecting anal continence. Despite much research, the aetiology and pathogenesis of CAAF remain poorly understood. Some anatomical, clinical and functional conditions or previous anal surgery

Fig. 2 Maximum resting pressure values (MRP) given in mmHg in the preoperative period and 6 months after surgery. A pointed area indicates the range of normal values of MRP

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or obstetric trauma could favour CAAF. Recently, Regadas et al. through 3-D anal endosonography have demonstrated an asymmetrical configuration of anal canal and the differences regard gender [14]. In the women, both external anal sphincter and IAS are shorter at the anterior level and are associated with a longer gap that could justify the higher incidence of pelvic floor dysfunction [14]. It is not known whether all or some women have slightly different pressure distribution in the distal anal canal predisposing them to develop CAAF more frequently than in men [15]. Ellis [16] reported that the patients with CAAF are frequently found to have a rectocele on physical examination and have a manometric profile typical of the patients affected by rectocele (high-pressure zone shortened with low to normal resting pressure) [17]. Great importance has been attributed to a previous obstetric trauma in the genesis of CAAF [18, 19]. Up to a third of women may develop sphincter damage after a first vaginal delivery and a significantly larger proportion are injured following a forceps delivery [20] or episiotomy. Also, after anal surgery such as manual dilatation, internal sphincterotomy, fistulotomy and haemorrhoidectomy, many patients have evidence of IAS injury and up to a third of patients may have an external anal sphincter injury [19]. Current practice in our unit is to avoid a sphincterotomy by using techniques that preserve sphincter activity especially for CAF where the role of hypertonia in their pathogenesis remains unclear. However, because the sphincter hypertonia determines a reduction of blood flow in the anoderm in all quadrant of anal canal [21], it seems to be logical reducing the sphincter hypertone for improving the healing process. There is no definitive evidence for using sphincter-preserving techniques, but it has been reported that even tailored, lateral sphincterotomy may inadvertently damage the external sphincter [22, 23]. Fissurectomy is the procedure most commonly used to preserve structural and functional integrity of the anal sphincters. Recently, Pelta et al. [24] have described a subcutaneous fissurotomy that involves de-roofing a narrow subcutaneous tract found caudal to the fissure and have reported a very high success rate and a low incidence of repeated surgery [24]. Fissurectomy is the excision of the anal fissure and it can be associated with the removal of the hypertrophied anal papilla and the skin tags. Fissurectomy, as a wound debridement, removes the bradytrophic scar tissue and creates fresh wound edges, creating in essence an acute fissure. Fissure excision without a procedure on the internal sphincter is an old operation and was championed by Ashton in 1854 [25]. It was recognized as effective therapy for CAF for many years, and afterwards it was abandoned due to its consequences such as keyhole deformity that may lead to faecal incontinence [7]; only recently it has been reconsidered for treating CAF in adults


with success [26–28]. The fissurectomy has been associated with surgical or pharmacological sphincterotomy. A few studies have investigated the use of fissurectomy with posterior midline internal sphincterotomy with acceptable results [29–32]. However, Melange et al. [33] found a 27% incidence of incontinence for flatus or liquid stool and a 9.2% incidence of passive soiling after the use of this technique [33]. The fissurectomy associated with reversible chemical sphincterotomy was first introduced in 2002 [34]. Among the drugs most commonly used for the pharmacological sphincterotomy, the botulinum toxin is better tolerated by patients due to high compliance associated with a low incidence of related side effects [35]. The botulinum toxin injection associated with the fissurectomy for the treatment of CAF has been reported by other authors [23, 36–38] with a high success rate and low morbidity. The botulinum toxin acts determining a weakness of internal sphincter with the reduction of MRP and improving the arterial blood flow in the anoderm. After fissurectomy, the use of a skin graft to cover the defect in treating CAF was first described in 1968 [39]. The rationale of advancing flaps of skin and fat is based on introducing a fresh blood supply to the ischaemic area of the fissure [40], reducing the time required for perianal wound healing and to avoid the risk of anal stenosis that follows healing by scarring [7]. This procedure has been performed selectively on patients with CAF without hypertonia of IAS [1, 18, 41, 42] or in the women [3, 43] or extensively, independently of CAF side and sphincter tone [44–46]. The results obtained have been good; in particular, a high healing rate, reduced incidence of complications and recurrences and complete preservation of anal continence has been reported [44]. However, to date, published reports were based only on a small sample size; only one study published in 1970 analysed a high number of procedures [46]. In our study, the patients with CAAF and high MRP values were treated with fissurectomy and advancement skin flap associated with the injection of 30 UI of botulinum toxin into the IAS. To our knowledge, this is the first study that reports this modality of treatment of CAAF. Good results have been achieved using this procedure: rapid relief of pain, complete healing in all cases, significant reduction of MRP and absence of recurrence at 12 months postoperative follow-up. The only complications recorded in the postoperative period were of slight entity and in no case required further surgery. This type of treatment removes the bradytrophic scar tissue through the fissurectomy to reduce healing time using an advancement flap and to reduce the hypertonia of IAS. This work is a pilot study. Randomized trials comparing fissurectomy alone versus fissurectomy combined with graft and fissurectomy associated with graft and drugs to

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reduce the sphincter tone are needed to better define their role in the treatment of CAAF with hypertonia of IAS.

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