Botulinum toxin injection versus lateral internal sphincterotomy for the treatment of chronic anal fissure: randomized prospective controlled trial

Purpose

Lateral internal sphincterotomy has been the gold standard treatment for chronic anal fissure, but it still carries the risk of permanent damage of the anal sphincter, which has led to the implementation of alternative treatment like botulinum toxin injection. The aim of this randomized prospective controlled trial was to compare the efficacy and morbidity of botulinum toxin injection and lateral internal sphincterotomy in the treatment of chronic anal fissure.

Methods

Fifty consecutive adults with chronic anal fissure were randomly treated with either lateral internal sphincterotomy or botulinum toxin (BT) injection with 50 U BT into the internal sphincter. The complications, healing and recurrence rate, and incontinence score were assessed 2, 3, 6, 12 months after the procedure.

Results

Inspection at the 2-month visit revealed complete healing of the fissure in 11 (44?%) of the patients in the BT group and 22 (88?%) of the patients in the lateral internal sphincterotomy (LIS) group (p?=?0.001). At the 3-month visit, there was no significant difference between the two groups in healing. The overall recurrence rate after 6 months in the BT group was higher than in the LIS group (p?<?0.05). In the 3-month follow-up, the LIS group had a higher rate of anal incontinence compared to the BT group (p?<?0.05). The final percentage of incontinence was 4?% in the LIS group (p?>?0.05).

Conclusions

The treatment of chronic anal fissure must be individualized depending on the different clinical profiles of patients. Botulinum toxin injection has a higher recurrence rate than LIS, and LIS provides rapid and permanent recovery. However, LIS carries a higher risk of anal incontinence in patients.     

The Treatment of Chronic Anal Fissure with Botulinum Toxin

Background /Aims: The aim of this study was to evaluate the effectiveness of botulinum toxin for the treatment of uncomplicated dorsal chronic idiopathic anal fissure.

Material and Methods: Forty-five patients who reported post defecatory anal pain since two months or more were given a total of 20U botulinum toxin in the anal sphincter apparatus on both sides as well as below the anal fissure. Results: Thirty-seven patients received a second session of 25U botulinum toxin injection. Thirty-five patients (78%) presented completely healed anal fissure, while ten needed lateral internal sphincterotomy. All patients were followed up for 8-36 months. Two patients relapsed.

Conclusion: Local injection of botulinum toxin is a new and safe treatment; however, two sessions of injections are necessary to be effective and long-term follow-up to assess the recurrence rate of fissure is needed to evaluate further this method of treatment. Partial internal lateral sphincterotomy is no more the treatment of choice for chronic anal fissure.     

Surgical versus chemical (botulinum toxin) sphincterotomy for chronic anal fissure: long-term results of a prospective randomized clinical and manometric study

BACKGROUND: The aim of this prospective randomized trial was to compare the effectiveness and morbidity of surgical versus chemical sphincterotomy in the treatment of chronic anal fissure after a 3-year follow-up. METHODS: Eighty patients with chronic anal fissure were treated by whether open lateral internal sphincterotomy (group 1) or chemical sphincterotomy with 25 U botulinum toxin injected into the internal sphincter (group 2). Clinical and manometric results were analyzed. RESULTS: Overall healing was 92.5% in the open sphincterotomy group and 45% in the toxin botulinum group (P<.001). There is a group of patients with clinical (duration of disease >12 months and presence of a sentinel pile before treatment) and manometric factors (persistently elevated mean resting pressure, % of time presence of slow waves, and number of patients or the time presence ultra slow waves after treatment) associated with a higher recurrence of anal fissure. The final percentage of incontinence was 5% in the open sphincterotomy group and 0% in the botulinum toxin group (P>.05). CONCLUSION: We recommend surgical sphincterotomy as the first therapeutic approach in patients with clinical and manometric factors of recurrence. We prefer the use of botulinum toxin in patients older than 50 years or with risk factors for incontinence, despite the higher rate of recurrence, since it avoids the greater risk of incontinence in the surgical group.     

Lateral Internal Sphincterotomy for Chronic Idiopathic Anal Fissure: An Alternative Approach

Background  

An alternative approach to lateral internal sphincterotomy in the management of chronic anal fissure is presented and its potential advantages are described.     

Comparative Study of Conventional Lateral Internal Sphincterotomy, V-Y Anoplasty, and Tailored Lateral Internal Sphincterotomy with V-Y Anoplasty in the Treatment of Chronic Anal Fissure

Background

Lateral internal sphincterotomy has been proven highly effective in curing anal fissure but with a high incidence of postoperative incontinence.

Objective

We compared conventional lateral internal sphincterotomy, V-Y advancement flap, and combined tailored lateral internal sphincterotomy with V-Y advancement flap in treating anal fissure.

Patients

Consecutive patients treated for anal fissure at our colorectal unit were evaluated for inclusion. Participants were randomly allocated to receive conventional sphincterotomy (GI), V-Y advancement flap (GII), or combined tailored lateral sphincterotomy with V-Y advancement l flap (GIII).

Main Outcome Measures

The primary outcome measure was the incontinence rate; secondary outcomes included healing rate, operative time, anal manometery, and recurrence rate.

Results

One hundred fifty patients with chronic anal fissure were randomized. Healing rate after 1?year was 84?% in GI, 48?% in GII, and 94?% in GIII, respectively (P?=?0.001). The recurrence rate was 4?% in G1, 22?% in GII, and 2?% in GIII (P?=?0.01). Incontinence rate was 14?% in GI, 0?% in GII, and 2?% in GIII (P?=?0.03).

Conclusion

Although all three procedures are simple and easy to perform, tailored lateral internal sphincterotomy with V-YF appears to produce the greatest healing rate, with the fewest complications and less rate of recurrence.     

Treatment of chronic anal fissure

Current treatment of chronic anal fissure continues to be based on conventional conservative measures in a high percentage of cases. What is known as chemical sphincterotomy aims to achieve a temporary decrease of anal pressures that allows fissures to heal. There are various alternatives such as nitroglycerine or diltiazem ointment and botulinum toxin injections. However, because of collateral effects and recurrences in the medium term, the definitive role of these treatments remains to be elucidated. Nevertheless, chemical sphincterotomy should be the first option in patients with a high risk of incontinence. "Open" or "closed" lateral internal sphincterotomy performed in the ambulatory setting with local anesthesia can currently be considered the ideal treatment of chronic anal fissure refractory to conservative measures so long as the patient is informed about the risk of minor incontinence. This procedure provides rapid and permanent recovery in more than 95% of patients. There is evidence demonstrating that the incontinence rate is related to the extent of the lateral internal sphincterotomy and consequently the extent of this procedure should be reduced to the length of the fissure.     

Nonsurgical treatment of chronic anal fissure: nitroglycerin and dilatation versus nifedipine and botulinum toxin.

BACKGROUND: Surgical sphincterotomy for chronic anal fissure can cause fecal incontinence. This has led to the investigation of nonsurgical treatment options that avoid permanent damage to the internal anal sphincter. METHODS: We conducted a retrospective, ongoing chart review with telephone follow-up of 88 patients treated for chronic anal fissure between November 1996 and December 2002. During the first half of the study period, patients were treated with topical nitroglycerin and pneumatic dilatation. With the availability of new therapies in June 1999, subsequent patients received topical nifedipine and botulinum toxin injections (30-100 units). Lateral anal sphincterotomy was reserved for patients who failed medical treatment. RESULTS: In 98% of patients the fissure healed with conservative nonsurgical treatment. The combination of nifedipine and botulinum toxin was superior to nitroglycerin and pneumatic dilatation with respect to both healing (94% v. 71%, p < 0.05) and recurrence rate (2% v. 27%, p < 0.01). There was no statistical difference between the number of dilatations and botulinum toxin injections needed to achieve healing. Three patients who received botulinum toxin reported mild transient flatus incontinence. At an average telephone follow-up of 27 months, 92% of patients reported having no pain or only mild occasional pain with bowel movements. CONCLUSIONS: Chronic anal fissures can be simply and effectively treated medically without the risk of incontinence associated with sphincterotomy. Topical nifedipine and botulinum toxin injections are an excellent combination, associated with a low recurrence rate and minimal side effects.     

Advancement flap in the management of chronic anal fissure: a prospective study

Lateral internal sphincterotomy is the surgical treatment of choice of chronic anal fissure after failure of conservative measures. Several randomized trials identified an overall risk of incontinence of 10 % mostly for flatus. Fissurectomy is the most commonly used procedure to preserve the integrity of the anal sphincters. However, a possible complication is keyhole defect that may lead to faecal soiling. In this study, chronic anal fissure (CAF) was treated by fissurectomy and anal advancement flap to preserve the anatomo-functional integrity of sphincters and to reduce healing time and the risk of anal stenosis. In patients with hypertonia, surgical treatment was combined with chemical sphincterotomy by injection of botulinum toxin to enhance tissue perfusion. Forty eight patients with CAF underwent fissurectomy and anal advancement flap. In 22 subjects with hypertonia of the internal anal sphincter, intrasphincter injection of 30 UI of botulinum toxin at the completion of the surgical operation was used. All patients were followed up to 24 months. Since the first defecation, the intensity and duration of pain were significantly reduced. Two patients had urinary retention, five had infections and three had partial breakdowns. No anal stenosis, keyhole deformity or necrosis flap was recorded. At the 24 months follow-up visit, anal incontinence was similar to those detected preoperatively. Only four recurrences were detected at 18 and 20 months. After medical treatment failure, fissurectomy with advancement flap is a valid sphincter-conserving procedure for treatment of anterior or posterior CAF, regardless of hypertonia of the internal anal sphincter.     

Treatment of chronic anal fissure

Chronic anal fissure is a common benign anorectal problem in Western countries that substantially impairs the patient's life. Consequently, a rapid and effective solution is required. We reviewed the various treatments for chronic anal fissure described in the literature, with the aim of establishing a therapeutic protocol. We recommend surgical sphincterotomy (preferably open or closed lateral sphincterotomy) as the first therapeutic approach in patients with chronic anal fissure. However, we prefer the use of chemical sphincterotomy (preferably botulinum toxin) in patients aged more than 50 years old and in those with previous incontinence, risk factors for incontinence (previous anal surgery, multiple vaginal births, diabetes, inflammatory bowel disease, etc.), or without anal hypertonia, despite the higher recurrence rate with medical treatments, since this procedure avoids the greater risk of residual incontinence described in the literature with surgical sphincterotomy in this group of patients.     

Treatment of chronic anal fissure using closed internal and lateral sphincterotomy

When the conservative treatment of the chronic anal fissure (nitrates, topical calcium channel blockers, topical nifedipine, lignocaine and cortisone compounds) proves to be inefficient, the surgery may be opted for. From among all surgical procedures (anal dilation, fissure excision, anal advancement flap) we have opted for closed internal and lateral sphincterotomy. During the period of 1990-2002, there have been performed by just one surgeon 47 sphincterotomies (15 men-32 women), average age 49 (23-76). Results: There has not been any case of anal incontinence for gases or faeces, precocious or late; 1 para anal hematoma (2.12%) solved through puncture; 2 anal abscesses (4.25%), solved through incision and tegmen drainage. Control in 6 month's time and 1 year time: normal quality of life, without any subjective complaints; painless rectal touch, healing of the fissure, extensible anal sphincter, normal continence. The sphincterotomy was followed by the disappearance of the cleft syndrome with all patients. Although the literature contains citations of transitory and minimum incontinence in 2-4% of the cases, we have not noticed in any; no recurrences have been registered; morbidity is acceptable. The future will decide if, between sphincterotomy and the injection with the botulinum toxin, the latter one is to be preferred.     

Anal Stretch Plus Fissurectomy for Chronic Anal Fissure

Introduction : Anal fissure is a common disease. Usually chronic anal fissures are managed medically. When conservative management fails, surgical treatment should be considered. Lateral internal sphincterotomy has been advocated as the first choice invasive treatment but it has a reported rate of major fecal incontinence of 5%. In order to reduce the onset of major fecal incontinence after anal fissure surgery, it has been proposed to use the anal stretching plus fissurectomy.

Methods : From 2008 to 2011, 457 patients have been operated for chronic anal fissure.

Results : Twenty-seven patients underwent lateral internal sphincterotomy, two patients underwent posterior sphincterotomy and 428 patients underwent anal stretch plus fissurectomy. Satisfactory results have been reported in 95% of the cases. Transient incontinence rates have been of 3% after anal stretch and of 14,8% after lateral internal sphincterotomy (p < 0,05). Major and persistent incontinence rates have been reported in a case after later internal sphincterotomy (3%) but never after anal stretching (p = 0,059). Recurrence occurred in 2% of the patients after anal stretch and in 3% of the cases after lateral internal sphincterotomy (p = ns).

Conclusion : Lateral internal sphincterotomy and anal stretch have nearly a reported 95% of good results but the first have 3–5% rates of major incontinence.     

Botulinum toxin for the treatment of anal fissure

BACKGROUND: The classic treatment for uncomplicated anal fissure is surgical sphincterotomy, i.e. cutting of the internal anal sphincter, thus eliminating spasm of this muscle and breaking the vicious circle of pain, spasm and inflammation. Recently, however, botulinum toxin has become available for the treatment of muscular dystonias, and thus for anal fissure. In the present study, we investigated the effectiveness of treatment with botulinum toxin in 76 patients with uncomplicated anal fissure. MATERIAL AND METHOD: The 76 patients received an injection of 40 U of botulinum toxin on each side of the fissure. Response was monitored 7, 30 and 90 days later. All patients who did not show clear improvement after 30 days received a second dose of 40 U on each side. RESULTS: After 90 days, 51 patients (67%) showed complete recovery, 19 patients (25%) substantial improvement though not complete recovery, and 6 patients (8%) no significant improvement. Transitory gas incontinence was reported by 2 patients (2.6%), and 1 patient presented hemorrhoidal thrombosis. DISCUSSION: Botulinum toxin enables chemical denervation of the internal sphincter, facilitating healing of the anal fissure. Its principal advantages with respect to surgical sphincterotomy are the absence of the general risks of surgery, and reduced incidence of incontinence, which even if it occurs tends to be transitory. The technique does not require hospitalization and is well tolerated. It appears suitable for the initial treatment of uncomplicated anal fissure, reserving surgical treatment for those cases which fail to response adequately.     

Idiopathic Hypertensive Anal Canal: A Place of Internal Sphincterotomy

Background  Hypertensive anal canal is frequently known to be associated with the presence of anal fissure. Based on clinical experience, we hypothesized that idiopathic anal sphincter hypertonia was a condition equivalent to anal fissure, and therefore, it could be treated the same way. Patient and methods  Sixty-three patients complaining of anal pain without any anal pathology and ten healthy volunteers were examined. All patients underwent clinical evaluation, neurological examination, anorectal manometry, and measurement of pudendal nerve terminal motor latency. All patients with hypertensive anal canal were randomized into three groups. Group I (surgical group) underwent closed lateral sphincterotomy (LS), group II using nitroglycerine ointment (GTN), and group III received injection of botulinum toxin in internal sphincter. Post-procedures data were recorded at follow-up period. Results  The mean resting anal pressure (MRAP) was significantly higher in the patient group (114.6 ± 7.4 mmHg) than control group (72.5 ± 6.6 mmHg, P < 0.001). Anal pain is the main presenting symptoms aggravated by defecation and not relived by analgesics or local anesthetics. After LS, pain visual analogue scale decreased significantly at follow-up period than after chemical sphincterotomy using GTN or BTX (P = 0.001). There was a significant decrease in MRAP postoperatively from 114.6 ± 7.4 to70.8 ± 5.5 mmHg than after using GTN or BTX (P = 0.03). Conclusion  Idiopathic hypertensive anal canal is a fact and already exists presented by anal pain aggravated by defecation. It can be managed safely by closed lateral sphincterotomy, but chemical sphincterotomy had a minor role in its management.     

Fissure-in-ano, to divide or not to divide?

Anal fissure is one of the most common and painful proctological pathologies affecting mainly young individuals. The physiopathology in the development of a chronic anal fissure seems to be a combination of internal anal sphincter hypertonia and poor vascularization at the posterior midline. Treatment of acute fissures is conservative with supportive therapy, leading to healing in the majority of the patients. Open or closed lateral internal sphincterotomy is the treatment of choice for chronic anal fissures. In low pressure chronic fissures, sphincterotomy should be avoided and a V-Y island advancement flap may be an alternative procedure. Sphincterotomy can induce anal incontinence, a feared complication of this technique. Recent interest has developed in chemical sphincterotomy with local botulin toxin injections or glyceryl trinitrate application. Long-term follow-up is needed to evaluate these new therapeutic options.     

Treatment of anal fissure by lateral subcutaneous internal sphincterotomy]

50 patients have been followed up after lateral internal sphincterotomy for chronic anal fissure. The results are excellent. This operation has some advantages over against the posterior sphincterotomy or the sphincter stretching and should replace these latter procedures in the treatment of chronic anal fissure. The lateral internal sphincterotomy may probably be applied for other benign anal lesions.     

A Study of Fecal Incontinence in Patients with Chronic Anal Fissure: Prospective,Randomized, Controlled Trial of the Extent of Internal Anal Sphincter Division During Lateral Sphincterotomy

Background Troublesome fecal incontinence following a lateral internal sphincterotomy is often attributed to faulty surgical technique. However, it may be associated with coexisting occult sphincter defects. Whether continence is related to the extent of sphincterotomy remains debatable. The aim of the study is to identify fecal incontinence related to chronic anal fissure before and after lateral internal sphincterotomy and its relationship to the extent of internal anal sphincter division. Methods One hundred eight patients with chronic anal fissure were prospectively studied before and after lateral internal sphincterotomy. A questionnaire was completed for each patient before and after surgery with regard to any degree of fecal incontinence. Fecal incontinence severity index was assessed using the Cleveland Clinic Incontinence Score. The patients with preoperative perfect continence were randomized into two groups (46 patients in each group): Group 1 underwent traditional lateral internal sphincterotomy (up to the dentate line) and Group 2 were underwent a conservative internal anal sphincterotomy (up to the height of the fissure apex or just below it). Results Minor degrees of incontinence were present before surgery in 16 patients (14.8%). Results of the randomized trial revealed that temporary postoperative incontinence was newly developed in 6/92 of patients (6.52 %) who did not have it before surgery. Five of the six (10.86%) were in Group 1 one (2.17%) was in Group 2 (p = 0.039). Persistent incontinence occurred in two in Group 1 (4.35%). All of them were females. All have had a history of one or more vaginal deliveries. Conclusion A mild degree of fecal incontinence may be associated with chronic anal fissure at presentation rather than as a result of internal sphincterotomy. Troublesome fecal incontinence after lateral internal sphincterotomy is uncommon. Sphincterotomy up to the dentate line provided faster pain relief and faster anal fissure healing, but it was associated with a significant postoperative alteration in fecal incontinence than was sphincterotomy up to the fissure apex. Care should be exercised in female patients with a history of previous obstetric trauma, as internal anal sphincter division may further compromise sphincter function.     

Long term outcomes after lateral anal sphincterotomy for anal fissure: a retrospective cohort study

Purpose

Lateral anal sphincterotomy is the gold standard of surgical treatment for anal fissure. Patients undergoing this procedure are warned about the risk of incontinence; however, there are few reports on long-term outcomes. We conducted this study to investigate long-term outcomes after lateral anal sphincterotomy, focusing specifically on postoperative incontinence.

Methods

Patients who underwent lateral anal sphincterotomy at a university teaching hospital between 1998 and 2004 were sent questionnaires to allow us to assess their continence according to the Cleveland Continence Score.

Results

The response rate was 58 % and the responders comprised 25 men and 13 women, with a median age of 49 years (range 16–82 years). The success rate for fissure healing following surgery was 92 %, being significantly more likely in patients with textbook symptoms (p = 0.016) and those with chronic disease (p = 0.006). The overall complication rate was 13.2 %. Long-term objective and symptomatic incontinence were reported by two (5.6 %) patients, one of whom required a colostomy.

Conclusion

Success rates after lateral anal sphincterotomy were satisfactory, but careful patient selection based on symptoms and disease chronicity may improve results further. Patients with predisposing risk factors for the development of incontinence, particularly multiparous women, are arguably better treated with non-surgical options.     

Comparative Study of Glyceryl Trinitrate Ointment Versus Surgical Management of Chronic Anal Fissure

Chronic Anal Fissure (CAF) is common perineal condition and well-known painful entity. Standard surgical treatment even though available, may require long hospital stay and sometimes have worrying complications like anal incontinence. So non-surgical treatment, Glyceryl Trinitrate has been shown to be an effective for chronic anal fissure. It decreases anal tone and ultimately heals the anal fissure. The present study is the attempt to know the efficacy of 0.2% Glyceryl Trinitrate ointment in the treatment of chronic anal fissure and to compare the effectiveness of 0.2% Glyceryl Trinitrate ointment (GTN) versus fissurectomy with lateral internal sphincterotomy (LIS) and fissurectomy with posterior internal sphincterotomy (PIS) in the management of chronic anal fissure. This is a prospective comparative study of management of chronic anal fissure done in our hospital during the period of one and half year from October 2005 to March 2007. Thirty patients treated with 0.2% Glyceryl Trinitrate ointment and 30 patients treated with fissurectomy and lateral internal sphincterotomy and 30 patients treated with posterior internal sphincterotomy, for chronic anal fissure were selected for study. A single brand of 0.2% Glyceryl Trinitrate ointment (Nitrogesic) used for trial arm. Dose of administration was 1.5 cm to 2 cm in the anal canal with device provided by manufacturers of the proprietary preparation and applied twice a daily for 12 weeks. Patients were followed up for 12 weeks and thereafter evaluated for relief of symptoms in all three groups. Observations were recorded at 2 weeks; 6 weeks and 12 weeks of follow up period, regarding symptoms like pain and bleeding during defecation, healing of CAF and also for side effects like headache in GTN group and flatus, fecal incontinence in surgical groups. Data collected in proforma and analyzed. Study revealed CAF was more in male 59 patients (66%) than the female 31 patients (34%), the ratio being 1: 0.52. The maximum number of patients was encountered in the age group of 20 to 40 years with mean duration of age 34.14 years. In all three groups symptoms like pain, bleeding, constipation and sphincter spasm were present. Sentinel pile was present in 56% of the patients. Common site of fissure was found to be posterior in 94% of patients. Observations with respect to relief of pain, no bleeding and healing were recorded at 2, 6 and 12 weeks of duration. Lateral sphincterotomy remains effective but should be reserved for the patients who fail to respond to initial chemical sphincterotomy or GTN therapy. GTN is good alternative mode of therapy for patients who refuse surgery and prefer medical line of treatment.     

小切口内括约肌侧切治疗陈旧性肛裂325例疗效观察

为探讨小切口内括约肌侧切治疗陈旧性肛裂的疗效,本研究采用此方法治疗陈旧性肛裂325例。结果显示,本组患者全部治愈,创面愈合时间为12～18d。术后疼痛较著者7例,发生直肠粪便嵌塞3例,腹泻2例。出院后1～2个月复查,肛门功能良好,外观无异常。结果表明,小切口内括约肌侧切治疗陈旧性肛裂操作简单,疗效确切,患者术后疼痛轻,并发症少,值得临床推广。     

Lateral internal sphincterotomy under local and spinal anaesthesia for chronic anal fissure: A randomised control trial

Introduction

Anal fissure is described as a linear defect, or laceration, in the anoderm, located between the dentate line and the anal verge. An acute fissure is a simple laceration, whereas a chronic anal fissure is an ulceration with built-up scarred edges and exposed internal anal sphincter muscle fibers at its base. Additional findings may include a perianal skin tag at the external margin of the fissure and a hypertrophied papilla at the dentate.

Methods

This is a randomised control study that included 50 patients, divided in two groups, who were treated with lateral internal sphincterotomyunder local anaesthesia (group A) and spinal anaesthesia (group B) in Dr. Ram Manohar Lohia Hospital, New Delhi, India, from May 2014 to November 2015. The follow-up period ranged from 2- 6 months.

Results

Fissure persistence or recurrence was found in 1 patient (4.16%) after 2 months in group B, and none in patients of group A. Wound healed by epithelization with mean of 1 week in group A, while it required 2 to 3 weeks for group B wounds to heal. There was wound infection in 5 out of 24 patients in group B (20.8%). There was no incontinence of flatus or stool in any of the patients in both groups.

Conclusions

Lateral internal sphincterotomy is now considered the treatment of choice for anal fissure, because it is a day care surgery, it causes less pain, it has negligible chances of recurrence and wound infection and is more effective in management of chronic anal fissure.