Diltiazem Ointment With Lidocaine vs. Nifedipine Ointment With Lidocaine Ointment for Treatment of Chronic Anal Fissure

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Anal fissure is a common anorectal diseases characterized by tear of the anoderm from the dentate line to the anal verge leading to pain and bleeding during and post defecation. It may be a benign disease, but patients suffering from disease report significantly impacted quality of life especially when it becomes chronic. Several treatment modalities have been studied for chronic anal fissure, and topical calcium channel blockers (CCB) showed promising benefit and side effect profile in treatment of chronic anal fissure. Topical Diltiazem and Nifedipine are currently widely used CCBs for chronic anal fissure after multiple studies showing their benefits compared to different agents or modalities. To the investigators' knowledge, there is no study comparing the efficacy of topical Diltiazem and Nifedipine directly. The investigators aim to design a pragmatic randomized clinical trial to compare the efficacy, and side effect profile of topical Nifedipine and Diltiazem in treatment of chronic anal fissure.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Treatments: Diltiazem; Lidocaine; Nifedipine

Criteria

Inclusion Criteria:

• History or clinical findings consistent with chronic anal fissure including symptoms (sharp pain during and post defecation, bleeding, or perianal irritation) with duration over 2 months

• Physical exam findings of sentinel anal skin tag, hypertrophied anal papilla, exposure of the underlying internal anal sphincter or anal cicatrization.

• Patient with history of trial of other topical agents for chronic anal fissure may be included for participation, but will be stratified based on previous treatment as they may be less likely to respond to another topical agent.

• Patient with concomitant hemorrhoids will also be included.

Exclusion Criteria:

• Patients with history of inflammatory bowel disease, perianal abscess, perianal fistula, anal cancer, anorectal instrumentation, trauma, surgery, radiation, obstetrical injuries, or current pregnancy will be excluded.