NCT07496216

Closed Versus Open Lateral Internal Sphincterotomy for Chronic Anal Fissure

Outcomes of Closed Versus Open Lateral Internal Sphincterotomy for Chronic Anal Fissure: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Services Hospital, Lahore · Other Government
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Anal Fissure

Interventions

Type	Name	Description
PROCEDURE	Closed Lateral Internal Sphincterotomy	A bivalve anal retractor will be inserted to visualize the intersphincteric groove. A number 11 scalpel blade will be introduced into the intersphincteric groove in the left lateral position, advanced to the level of the dentate line, and then rotated medially to divide the internal anal sphincter. A dry gauze wick soaked with xylocaine gel will be placed in the anal canal for hemostasis and removed on the evening of the operation day.
PROCEDURE	Open Lateral Internal Sphincterotomy	A 1-2 cm curvilinear incision will be made in the intersphincteric groove in the left lateral position. The intersphincteric plane will be dissected to expose the internal anal sphincter, which will then be divided under direct vision up to the level of the dentate line. The wound will be left open to heal by secondary intention.

Timeline

• Start date: 2019-02-01
• Primary completion: 2025-12-31
• Completion: 2026-01-15
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Pakistan