Conservative versus surgical treatment for chronic anal idiopathic fissure: a prospective randomized trial.

Anal fissure is a tear in the lining of the anal canal distal to the dentate line, which most commonly occurs in the posterior midline. Anal fissure was defined chronic if the patient presented with history of anal pain during defecation for at least 2 months with the observation of sphincter fibers at the base of the lesion. One hundred and forty-two consecutive patients with a chronic anal fissure with hypertonicity of internal sphincter on proctological examination were selected for this study from October 2008 to October 2010. Patients enrolled for the study were randomized to two groups by using a computer-generated list. Patients who underwent lateral internal sphincterotomy (LIS) were operated as day surgery procedures under local or epidural anesthesia. Patients randomized to conservative treatment were prescribed to use warm anal dilator with a nifedipine ointment 5 min twice daily for 4 weeks. Patients were clinically examined after 2, 4 and 8 weeks of treatment to evaluate if there was complete healing of the fissure. All patients were required to record pain after the first defecation, on 3rd and 7th postoperative day on a self-administered VAS scale in cm (0-10). Sixty-eight patients were randomly assigned to LIS, 74 to the conservative approach. Fifty-one patients of topical nifedipine group (68.9 %) and 60 patients of LIS group (88.2 %) presented an anal fissure healed at 8 weeks with a p value of 0.0077. As regards post-operative pain, 43 patients of LIS group (63.2 %) and 25 patients of topical nifedipine group (33.7 %) referred first defecation as painless. In the topical nifedipine group 43 (58.1 %) after 3 days since treatment and 35 (47.3 %) after 7 days had pain. In the LIS group 22 (32.3 %) after 3 days and 9 (13.2 %) after 7 days referred pain. There was no statistical difference between LIS and topical nifedipine group concerning side effects. Lateral internal sphincterotomy is an effective, less painful, fast recovery treatment for chronic anal fissure. Incontinence rate is overestimated and often the fear of a continence disturbance, albeit with a low incidence following surgery, may obscure the need to relieve symptoms which may be so severe as to make the patient's life intolerable.

RCT Entities:   Population Interventions Outcomes