Clinical Trial

Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure

Study acronym: SPHINX
Recruiting
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Summary
This prospective randomized controlled trial compares three lateral internal sphincterotomy (LIS) techniques in patients with chronic anal fissure refractory to medical treatment: (1) Spasm-Controlled LIS (serial small sphincterotomies using an anal calibrator until 30 mm anal caliber is achieved, under local anesthesia plus sedation), (2) LIS up to the Fissure Apex (spinal or general anesthesia), and (3) LIS up to the Dentate Line (spinal or general anesthesia). The primary outcomes are fissure healing rate and fecal incontinence incidence at 12 months, assessed using the Wexner Incontinence Score. Secondary outcomes include postoperative pain (VAS), recurrence rate, patient satisfaction, and complications. A total of 150 patients (50 per group) will be enrolled and followed for 12 months.
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-15
Trial Details
NCT Number NCT07520552
Lead Sponsor Çanakkale Onsekiz Mart University
Conditions Chronic Anal Fissure
Enrollment 150 participants
Start Date 2026-05-06
Primary Completion 2027-05-06 (estimated)
Study Completion 2028-05-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-14