Randomized clinical trial of 0.2 per cent glyceryl trinitrate ointment for wound healing and pain reduction after open diathermy haemorrhoidectomy

BACKGROUND: Open haemorrhoidectomy is associated with considerable postoperative pain and discomfort. This study assessed whether glyceryl trinitrate (GTN) ointment promotes wound healing and reduces pain after open haemorrhoidectomy. METHODS: A randomized prospective double-blind placebo-controlled trial was conducted. Patients were randomized to either 0.2 per cent GTN ointment or placebo ointment (petroleum jelly). Patients were asked to fill in a pain diary. Complete healing was defined as complete epithelialization. RESULTS: There were 40 patients in the GTN group and 42 in the placebo group. There were no statistically significant differences in sex, weight, type of haemorrhoid, type of surgery (emergency or elective), number of haemorrhoids excised, duration of surgery, hospital stay and complication rate between the groups. Pain scores and analgesic use were not significantly different. By week 3, however, 17 patients in the GTN group had completely epithelialized wounds compared with eight patients in the placebo group (P = 0.021). Only one patient who received GTN experienced headache requiring discontinuation of the ointment. CONCLUSION: TGN 0.2 per cent ointment improved wound healing rates, but did not reduce pain in this study.     

Influence of botulinum toxin site of injections on healing rate in patients with chronic anal fissure

BACKGROUND: Botulinum toxin induces healing in patients with idiopathic anal fissure. METHODS: Fifty patients affected by posterior anal fissure were treated with 20 units of botulinum toxin, injection in the internal anal sphincter on each side of the posterior midline (group I) or on each side of the anterior midline (group II). RESULTS: At 2 months evaluation, a healing scar was observed in 15 patients of group I and in 22 patients of group II(P = 0.025). Resting anal pressure was significantly different from the baseline values at 1-month as well as at 2-month check-ups in both groups, but the values were significantly lower in patients of group II. CONCLUSIONS: The intersite comparison revealed that anterior injection of the internal anal sphincter resulted in improved lowering of resting anal pressure and produced an earlier healing scar.     

Randomized clinical trial comparing oral nifedipine with lateral anal sphincterotomy and tailored sphincterotomy in the treatment of chronic anal fissure

BACKGROUND: The conventional treatment of chronic anal fissure is lateral sphincterotomy (LAS). The alternative options of tailored sphincterotomy (TS) and 'chemical sphincterotomy' using medication such as nifedipine have recently become available. METHODS: A prospective randomized trial was conducted to compare LAS with TS and oral nifedipine. The main endpoints were fissure healing, symptom relief, recurrence and continence. RESULTS: One hundred and thirty-two patients were treated and followed up for 4 months. LAS was significantly more effective than TS in providing pain relief (P = 0.004) and better patient satisfaction (P = 0.020) at 4 weeks. Surgery (LAS and TS) was associated with significantly better fissure healing rates (both P < 0.001 at 16 weeks) and less recurrence (both P = 0.003) than nifedipine. There were substantial problems with compliance in the nifedipine group (17 of 41 patients), related to side-effects and slow healing. There were no differences in continence between the three treatment groups. CONCLUSION: LAS was most effective in providing pain relief and allowing rapid fissure healing, with minimal recurrence and no increased risk of incontinence, in patients with good anal sphincter function.     

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.     

What predicts successful nonoperative management with botulinum toxin for anal fissure?

BackgroundBotulinum toxin has been established as a non-surgical alternative for chronic anal fissures. There is a paucity of data regarding which patients benefit most from this intervention. Methods: We retrospectively collected data from all cases of chronic anal fissures treated with botulinum toxin over seven years to identify predictors of success. Non-responders were defined as any subsequent surgery or reporting satisfaction as poor or fair. Results: Of 91 patients, 60% (n = 55) were responders and 26% (n = 25) underwent subsequent surgery. There were significantly more females among responders (78% vs. 55%, p = 0.02). A higher body mass index tended towards significance among non-responders (30 ± 7 vs. 27 ± 6, p = 0.08). High satisfaction at the first visit was associated with no subsequent surgery (18% vs. 45%, p = 0.002). Conclusions: Botulinum toxin can be successfully used to treat anal fissures in a majority of patients. Primary predictors of success were female sex, satisfaction at the first post-procedure visit and there was a tendency towards a lower body mass index.     

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.     

硝酸甘油软膏加扩肛与单纯扩肛治疗肛裂96例对照观察

目的探讨扩肛加硝酸甘油软膏治疗肛裂的临床效果。方法将2011年5月至2011年10月到常州市中医医院治疗的96例Ⅱ、Ⅲ期肛裂患者,随机分为两组,在常规扩肛术的基础上于肛裂创面外用硝酸甘油软膏治疗49例为治疗组,单纯扩肛治疗47例为对照组。结果 96例患者随访时间3～6个月。治疗组复发2例,治愈率95.9%,对照组复发9例,治愈率80.9%,两组比较差异有统计学意义,P<0.05。结论肛裂行扩肛术后局部再外用硝酸甘油软膏,有利于肛裂的治愈,减少并发症的发生。     

A prospective randomized trial of diltiazem and glyceryltrinitrate ointment in the treatment of chronic anal fissure

Objective The aim of this study was to compare prospectively diltiazem with GTN ointment in the treatment of anal fissure. Patients and methods Of 43 outpatients with chronic anal fissure, 22 patients were randomized to topical diltiazem (2%) ointment and 21 patients to glyceryltrinitrate (GTN) (0.5%) ointment twice daily for 8 weeks. During the course of treatment each patient was seen three times. Side‐effects and healing were recorded. Results Healing occurred in 19 of 22 patients treated with diltiazem and 18 of 21 patients were cured with GTN (P = 0.95). Those who were treated with nitroglycerin ointment developed headache and dizzness developed after GTN in 33.3% of cases while no patient had any side‐effects after diltiazem. Conclusions Diltiazem and glyceryltrinitrate (GTN) were equally effective in healing anal fissure but the former resulted in fewer side‐effects.