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.     

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.     

控制性括约肌侧切术治疗陈旧性肛裂的临床疗效

为探讨控制性括约肌侧切术治疗陈旧性肛裂的疗效，将118例陈旧性肛裂患者随机分为两组，分别采用控制性内括约肌侧切术（治疗组）和传统的内括约肌侧切扩肛术（对照组）治疗，并对比分析两组治疗结果。结果显示，两组患者均一次性治愈，均无大便失禁发生。但治疗组和对照组分别有1例和6例肛门气体失禁。随访至今，治疗组无复发，对照组复发1例。结果表明，控制性括约肌侧切术减少了不必要的组织损伤，更好地保护了肛门功能，可～次性治愈陈旧性肛裂，且操作简单，适合基层医疗单位推广应用。     

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.     

Internal sphincterotomy for chronic anal fissure: long term effects on anal pressure

In 28 patients with chronic anal fissure the median anal canal pressure was 98 cmH2O, significantly higher than in control subjects (P less than 0.001). After lateral internal sphincterotomy the pressure dropped by 50 per cent to normal levels and the fissures healed with no change in pressure over 12 months. Ten patients also had normal anal pressures and were asymptomatic 4-6 years after internal sphincterotomy. Adequate internal sphincterotomy appears to reduce permanently anal canal pressure, suggesting that abnormal activity in the sphincter contributes to the development of a fissure.     

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。     

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.     

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.     

Keyhole Deformity: A Case Series

Objective Keyhole deformity is frequently encountered after posterior internal sphincterotomy but may be observed after lateral internal sphincterotomy or in patients without any history of previous anal surgery. The aim of the present study is to emphasize the surgical significance of this entity and discuss the possible strategies in the treatment of the deformity. Material and Methods Patients in whom keyhole deformity developed after surgical or conservative treatment applied for chronic anal fissure in our clinic and patients referred from other centers were recruited. Results Nine-hundred twenty-six patients were treated for chronic anal fissure. A hundred of these patients directly underwent lateral internal sphincterotomy. The remaining 826 patients initially received conservative management, and 676 of them eventually underwent lateral internal sphincterotomy. In total, 15 patients were diagnosed to have significant keyhole deformity. Initially, all patients received conservative treatment for keyhole deformity, which was successful in two patients. Of the 13 patients in whom conservative management failed, nine underwent advancement flap reconstruction and the remaining four diamond flap reconstruction. Conclusion Keyhole deformity is occasionally seen as a late complication of chronic anal fissure and may be well tolerated by the patients without any well-defined symptoms. The treatment strategy is directed toward the degree of functional alteration. This study was presented at the 11th Meeting of the Turkish Society of Colon and Rectal Surgery, Bodrum, August 26–30 2007.     

Quality of life assessment in patients with chronic anal fissure after lateral internal sphincterotomy

BACKGROUND: The aim of this study was to compare quality of life of patients with chronic anal fissure before and after open lateral internal sphincterotomy. METHODS: A prospective study was undertaken of 108 consecutive patients with a history of chronic anal fissure who underwent lateral internal sphincterotomy. Quality of life was measured before and 6 months after operation with the Short-Form 36 (SF-36) Health Survey. RESULTS: Quality of life improved significantly in six of the eight scales of the SF-36 questionnaire: physical functioning, role physical, bodily pain, energy, social functioning and mental health. There were no significant differences between the 70 patients who had no change in continence after operation and the 38 patients with continence disturbances after sphincterotomy. However, there were significant improvements in four scales in patients without changes in continence compared with improvements in only two scales in those with continence disturbances. CONCLUSION: Patients with chronic anal fissure showed an improvement in quality of life 6 months after internal lateral sphincterotomy. Patients with postoperative continence disturbances showed improvement in fewer scales of the SF-36 questionnaire than those without changes in continence.     

Changing patterns of treatment for chronic anal fissure.

To assess changing patterns of treatment for chronic anal fissure, a retrospective analysis of treatment for chronic anal fissure within one hospital between January 1990 and December 1996 was undertaken. A total of 221 patients received treatment for a chronic anal fissure in this period, of whom 209 had a surgical procedure. Manual dilatation of the anus was performed in 21 patients (10%) and has not been performed since 1995. Lateral internal sphincterotomy was performed in 183 patients (88%) and continues to be the mainstay of treatment. Five female patients (2%) were identified as having a sphincter defect by anal manometry combined with endoanal ultrasound and were treated by an anal advancement flap. From 1996 onwards, 15 patients (7%) were treated by topical glyceryl trinitrate (GTN) paste as the first line of treatment. Of these patients, nine have experienced healing of their fissure, and three have had relief of pain without healing of the fissure. Three have gone on to have a lateral internal sphincterotomy. Lateral internal sphincterotomy remains the primary form of treatment for chronic anal fissure. GTN cream has increasingly been offered as preliminary treatment over the last 12 months. Perioperative use of endoanal ultrasound allowed identification of patients who may be at high risk of postoperative incontinence from a sphincterotomy. An anal advancement flap has been used as an alternative surgical approach for these patients.     

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.     

慢性肛裂手术治疗进展

目的总结目前肛裂手术治疗的研究进展。方法收集近年来国内外关于肛裂的各种手术治疗方式的相关文献并作综述。结果肛裂的手术治疗方法较多,包括闭合式或开放式侧方内括约肌切开术、肛裂切除术、皮瓣成形术及其他手术方式;不同的手术方法各有优缺点,但都存在一定比率的并发症发生率和复发风险。结论对于哪种术式最适合于治疗陈旧性肛裂尚无统一定论。     

Stapled haemorrhoidopexy for haemorrhoids in combination with lateral internal sphincterotomy for fissure-in-ano

The aim of this prospective study is to describe the combined technique and results of stapled haemorrhoidopexy and lateral internal sphincterotomy for patients suffering from prolapsing 3rd-degree haemorrhoids and chronic fissure-in-ano. During the period from 1999 to 2004, 26 patients underwent combined surgical treatment for anal fissure and prolapsing symptomatic haemorrhoids. Preoperative and postoperative clinical evaluation and the patient's degree of satisfaction were recorded. Early complications included faecal urgency (3 patients) and pain (2 patients). Complete continence was restored within 10 weeks in all patients except 1 who had persisting incontinence to flatus. All fissures healed completely within 4 weeks. No haemorrhoidal or fissure recurrence has been observed during follow-up. The combination of stapled haemorrhoidopexy and lateral internal sphincterotomy is a safe and effective procedure for the treatment of prolapsing 3rd-degree haemorrhoids and chronic anal fissures.     

闭式切除术结合皮瓣移行治疗前位肛裂效果观察

目的 探索后矢状位闭式切除部分内括约肌结合皮瓣移行治疗前位肛裂,与单纯肛裂切除敞开疗法对照,比较临床疗效.方法 48例前位Ⅲ期肛裂患者随机分为治疗组和对照组各24例.治疗组采用闭式切除结合皮瓣移行法,对照组采用单纯肛裂切除敞开疗法,术前术后处理相同.结果 术后6个月复发率治疗组低于对照组(P＜0.01),近期治愈率,手术并发症无统计学意义(P＞0.05).结论 临床观察表明,闭式切除术结合皮瓣移行法具有松解内括约肌,愈合时间短,疼痛降低等优点,是治疗前位Ⅲ期肛裂较好的术式.     

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.     

Fissurectomy and isosorbide dinitrate for chronic fissure in ano not responding to conservative treatment

BACKGROUND: Although lateral sphincterotomy heals chronic fissure in ano in over 90 per cent of cases it is a surgical technique with inherent complications. To avoid such complications, chronic fissure in ano was treated by fissurectomy in this study. To enhance postoperative tissue perfusion allowing stable wound healing, fissurectomy was combined with temporary chemical sphincterotomy by a nitric oxide donor cream. METHODS: Seventeen consecutive patients (ten women) with chronic fissure in ano not responding to conservative management underwent diathermy fissurectomy. After operation patients used a 1 per cent isosorbide dinitrate cream. Postoperative follow-up continued until wounds had healed, at which time anal endosonography was performed. A telephone inquiry into fissure recurrence and continence status was made. RESULTS: Seventeen patients underwent fissurectomy, without postoperative complications. All wounds had healed within 10 weeks. No fissure recurrence was seen after a median follow-up of 29 months. Histopathology showed non-specific scar tissue without signs of internal anal sphincter fibrosis. Postoperative endosonography showed no evidence of new internal sphincter defects. CONCLUSION: In the treatment of chronic anal fissure not responding to chemical sphincterotomy with nitric oxide donors, fissurectomy in combination with isosorbide dinitrate cream may be a sphincter-sparing surgical technique.     

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.     

不同手术方式治疗慢性肛裂疗效评价的网状Meta分析

目的评价不同手术方式治疗慢性肛裂的效果。 方法通过计算机检索传统肛裂切除术、纵切横缝法、改良纵切横缝术、肛裂切除术+外括约肌切开术、肛裂切除术+内括约肌切开术5种手术治疗慢性肛裂的国内外临床研究，采用Stata13及GeMTC软件对其治愈率和并发症发生率进行传统Meta分析和网状Meta分析。 结果共纳入21项临床研究2 430例患者。网状Meta分析显示肛裂切除术+内括约肌切开术和肛裂切除术+外括约肌切开术的治愈率均高于传统肛裂切除术，OR值分别为2.27（95%CI=1.14~4.36）、3.26（95%CI=1.67~6.75）。在并发症的发生率方面，纵切横缝术、传统肛裂切除术排前两位，肛裂切除术+内括约肌切开术最低。 结论在5种常见的慢性肛裂手术方式中，肛裂切除术+内括约肌切开术的疗效和并发症发生均优于传统肛裂切除术、纵切横缝法、改良纵切横缝术、肛裂切除术+外括约肌切开术。     

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.