CompletedNot Applicable

Closed Versus Open Lateral Internal Sphincterotomy for Chronic Anal Fissure

Pakistan160 participantsStarted 2019-02-01

Plain-language summary

This randomized controlled trial will compare closed versus open lateral internal sphincterotomy (LIS) under spinal anesthesia in patients with chronic anal fissure. The study will evaluate wound healing rates, postoperative pain, return to work, anal incontinence, and recurrence. A total of 160 patients will be randomized equally to either closed LIS or open LIS. The primary outcome will be complete wound healing at 6 weeks. Secondary outcomes include pain at 24 hours measured by Visual Analog Scale (VAS), return to work (days), anal incontinence at 6 weeks and 1 year, and recurrence at 1 year. Multivariate analysis will identify independent predictors of non-healing.

Who can participate

Age range20 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of chronic anal fissure (symptoms \> 6 weeks) * Failure of conservative medical management (dietary fiber, stool softeners, topical lignocaine, and at least 4 weeks of topical glyceryl trinitrate 0.2%) * Willing to provide informed consent Exclusion Criteria: * Multiple fissures * Concomitant anorectal pathology (anal fistula, abscess, significant hemorrhoids, rectal cancer) * Inflammatory bowel disease * Previous anorectal surgery * History of anoreceptive intercourse * Psychiatric disease or inability to consent

What they're measuring

Number of Patients with complete wound healing

Timeframe: 6 weeks

Anal incontinence

Timeframe: 6 weeks

Trial details

NCT IDNCT07496216

SponsorServices Hospital, Lahore

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Chronic Anal Fissure trials