Postero-lateral Internal Sphincterotomy vs Botulinum Toxin Injection in the Treatment of Chronic Anal Fissure

• Status: Recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

We hypothesized that optimization of the dose of the Botulinum toxin injection (BT) and standardization of the technique of lateral internal sphincterotomy to posterolateral internal sphincterotomy (PIAS) could, in turn, report a conclusive result which helps to provide better care to patients with chronic anal fissure. So, we will conduct this trial as a prospective randomized, controlled, intervention, open-label trial with two parallel groups, and a primary endpoint of fissure healing during 6 months after the initial intervention, with the randomization, will be performed by an online software with a 1:1 allocation. Eligible patients will be randomized in equal proportions between BT injection and PIAS.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Botulinum Toxins

Criteria

Inclusion Criteria:

• Chronic anal fissure lasting more than 6 weeks

Exclusion Criteria:

• Pregnant

• cardiovascular disease or heart failure

• on antihypertensive medications

• recurrent anal fissure after previous sphincterotomy

• prior history of anal surgery

• other benign anorectal diseases

• with inflammatory bowel diseases