Status:
UNKNOWN
Diltiazem Ointment With Lidocaine vs. Nifedipine Ointment With Lidocaine Ointment for Treatment of Chronic Anal Fissure
Lead Sponsor:
University of Calgary
Conditions:
Fissure in Ano
Rectal Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 dis...
Detailed Description
Anal fissure is a common anorectal diseases characterized by tear of the anoderm from the dentate line to the anal verge. It is a benign disease, but symptoms including stabbing pain during and post d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT04887818
Start Date
June 1 2021
End Date
December 1 2021
Last Update
May 14 2021
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 2T9