Botulinum Toxin Injection Versus Lateral Internal Sphincterotomy in the Treatment of Chronic Anal Fissure: A Randomized Controlled Trial

Background  

Although lateral internal sphincterotomy has been the gold standard of treatment for chronic anal fissure, the main concern remains its effects on anal continence. Intrasphincteric injection of botulinum toxin seems to be a reliable option providing temporary alleviation of sphincter spasm and allowing the fissure to heal. The aim of the present prospective controlled randomized study was to compare the outcome of lateral internal sphincterotomy and botulinum toxin injection treatments in patients with uncomplicated chronic anal fissure.     

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.     

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.     

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.     

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.     

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

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.     

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.     

Randomized clinical trial comparing botulinum toxin injections with 0.2 per cent nitroglycerin ointment for chronic anal fissure

BACKGROUND: In recent years treatment of chronic anal fissure has shifted from surgical to medical. This study compared the ability of two non-surgical treatments-botulinum toxin injections and nitroglycerin ointment-to induce healing in patients with idiopathic anal fissure. METHODS: One hundred adults were assigned randomly to receive treatment with either type A botulinum toxin (30 units Botox or 90 units Dysport) injected into the internal anal sphincter or 0.2 per cent nitroglycerin ointment applied three times daily for 8 weeks. RESULTS: After 2 months, the fissures were healed in 46 (92 per cent) of 50 patients in the botulinum toxin group and in 35 (70 per cent) of 50 in the nitroglycerin group (P=0.009). Three patients in the botulinum toxin group and 17 in the nitroglycerin group reported adverse effects (P<0.001). Those treated with botulinum toxin had mild incontinence to flatus that lasted 3 weeks after treatment but disappeared spontaneously, whereas nitroglycerin treatment was associated with transient, moderate-to-severe headaches. Nineteen patients who did not have a response to the assigned treatment crossed over to the other therapy. CONCLUSION: Although treatment with either topical nitroglycerin or botulinum toxin is effective as an alternative to surgery for patients with chronic anal fissure, botulinum toxin is the more effective option.     

Internal anal sphincter function following lateral internal sphincterotomy for anal fissure: a long-term manometric study

BACKGROUND: Anal fissure is a common and painful disorder. Its relation to hypertonic anal sphincter is controversial. The most common surgical treatment of chronic anal fissure is lateral internal sphincterotomy. OBJECTIVE: The aim of this study was to evaluate long-term manometric results of sphincter healing following lateral internal sphincterotomy. PATIENTS AND METHODS: Between 2000 and 2003, 50 patients with anal fissure were included in this study and underwent sphincterotomy; 12 healthy patients served as controls. All patients with anal fissure underwent manometric evaluation using a 6-channel perfusion catheter. All patients were examined 1 month before surgery and 1, 3, 6, and 12 months following surgery. The control group had 3 manometric evaluations 6 months apart. RESULTS: The mean basal resting pressure before surgery was 138 +/- 28 mm Hg. One month after surgery, the pressure dropped to 86 +/- 15 mm Hg (P < 0.0001) and gradually rose to a plateau at 12 months (110 +/- 18 mm Hg, P < 0.0001). At 12 months, the manometric pressure was significantly lower than the baseline (P < 0.0001). However, manometric measurements in the fissure group were still significantly higher than in the control group (110 +/- 18 versus 73 +/- 4.8 mm Hg, P < 0.0001). All patients were free of symptoms at the 12-month follow-up. CONCLUSION: Lateral internal sphincterotomy caused a significant decline in the resting anal pressure. During the first year following surgery, the tone of the internal anal sphincter gradually increased, indicating recovery, but still remained significantly lower than before surgery. However, postoperative resting pressures were higher than those in the control, and no patient suffered any permanent problems with incontinence, so this decrease may not be clinically significant.     

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.     

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.     

Randomised trial of topical 0.2% glyceryl trinitrate and lateral internal sphincterotomy for the treatment of patients with chronic anal fissure: long-term follow-up.

OBJECTIVE: To compare outcomes 24 months after treatment of chronic anal fissure with 0.2% glyceryl trinitrate ointment (GTN) or lateral internal sphincterotomy. DESIGN: Prospective, randomised trial. SETTING: One teaching, one private, and 3 district hospitals, U.K. SUBJECTS: Seventy patients were randomised into two groups of 35 each to use 0.2% GTN ointment or have a lateral internal sphincterotomy. MAIN OUTCOME MEASURES: Resolution of symptoms and healing of fissures assessed after 24 months. RESULTS: All those operated on were initially cured but one fissure recurred after 8 months. Nineteen of 35 fissures treated with GTN healed. The remaining 16 patients randomised to use GTN ointment whose fissures did not heal were then treated by sphincterotomy. Three patients whose fissures healed successfully with GTN developed recurrences within 6 months of completing treatment. The remaining 16 of 19 patients treated with GTN whose fissures healed were free of symptoms with no clinical evidence of recurrence after 24 months follow-up. CONCLUSIONS: Many anal fissures heal with topical treatment with GTN. Lateral internal sphincterotomy remains effective but should be reserved for patients who fail to respond to initial chemical sphincterotomy.     

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.     

Botulinum toxin in the treatment of refractory constipation associated with anal sphincter hypertonicity: A pilot prospective study in Chinese children (CME paper)

Objective: Idiopathic constipation in children can be difficult to manage with conventional therapies. The present study aimed to evaluate the efficacy of adjunctive botulinum toxin injection in children attending our regional centre with refractory idiopathic constipation associated with internal anal sphincter hypertonicity. Methods: Children suffering refractory constipation after a minimum of 3 months bowel training, dietary and laxative treatments were evaluated by anorectal manometry. Those with idiopathic anal sphincter hypertonicity (resting pressure > 60 mmHg with normal recto‐anal reflex) were recruited for botulinum toxin injection. Pretreatment evaluation also included bowel‐function score and the degree of megarectum as measured transpubically by ultrasound. Each child received 60 units of Botox^® intrasphincterically under general anaesthesia. Follow‐up evaluations were carried out at 6 weeks and 6 months. Results: Eleven Chinese children, mean age 6.1 years, underwent botulinum toxin treatment. The mean sphincter pressure decreased from 73 mmHg to 55 mmHg and the mean symptom score improved from 2.5 to 6.3 (P = 0.003, Wilcoxon signed rank‐sum test). The mean rectal diameter decreased from 3.7 cm to 3.4 cm. Findings were sustained at 6 months with no treatment complications. Conclusion: Botulinum toxin intrasphincteric injection is a safe, non‐invasive and effective adjunct to conventional therapies in managing children with refractory idiopathic constipation associated with sphincter hypertonicity. Timely definitive therapy to facilitate pain‐free habitual defecation plays an important role in these children in their potty training, as demonstrated by the sustained ‘sphincterotomy’ effects outlasting the transient toxin paralysis.     

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.     

Injections of botulinum A toxin for the treatment of anal fissures.

OBJECTIVE: To find out how injections of botulinum A toxin influence the healing of anal fissures. DESIGN: Retrospective study. SETTING: Medical University of Lodz, Poland. SUBJECTS: 13 patients (6 women, 7 men), mean age 49 (range 31-78), treated with injections of botulinum A toxin 50 units on either side of the anal fissure into the internal anal sphincter from May to December 1999. MAIN OUTCOME MEASURES: Complications and relapse. RESULTS: Seven fissures had healed by one month and four by two months. Two remained unhealed but asymptomatic. There was no incontinence of flatus or faeces after three months of treatment. Resting anal pressure was significantly lower in 10 of 13 patients compared with before treatment (p < 0.05). One fissure relapsed after 4 months and this patient had a successful anal stretch. CONCLUSION: Injection of botulinum A toxin gives good results in the treatment of anal fissures.     

Topical nitroglycerin versus lateral internal sphincterotomy for chronic anal fissure: prospective, randomized trial

Introduction: Topical nitroglycerin (GTN) is one of the medical treatments of choice in chronic anal fissure. The present prospective, randomized, clinical trial was conducted to study the symptomatic relief, healing, and changes in the maximum anal resting pressure (MARP) in patients with chronic anal fissure comparing topical GTN and lateral sphincterotomy. Methods: Forty consecutive patients with chronic anal fissure were randomized for treatment with either topical GTN or internal sphincterotomy (20 patients in each group). Anal manometry was done before treatment in all patients, and 1 h after application of GTN or sphincterotomy. Patients were followed at 2‐weekly intervals for 6 weeks for symptomatic relief and healing. Results: Both GTN and sphincterotomy brought about a highly significant, but comparable drop in the MARP after treatment (P < 0.0001 in both groups). Sphincterotomy relieved pain much earlier compared to GTN (70% vs 40% at 2 weeks, P = 0.0032); but after 4 weeks of treatment, pain relief in both groups was comparable. Healing in the sphincterotomy group was also earlier than with GTN (55% vs 0% at 2 weeks, P < 0.0001; and 85% vs 30% at 4 weeks, P < 0.0001); but after 6 weeks, healing in both groups was comparable. Sphincterotomy had a significant incidence of minor, short‐term complications; it also required surgical expertise, theatre time, and day‐care beds. Nitroglycerin is safe, with mild and tolerable side‐effects of headache and local burning sensation. Conclusion: Topical GTN should be the initial treatment in chronic anal fissure. Lateral sphincterotomy should be reserved for patients with severe disabling pain (because pain relief is much faster), and for patients not responding to at least 4 weeks of GTN therapy.     

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。