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Closed Versus Open Lateral Internal Sphincterotomy for Chronic Anal Fissure

NCT07496216 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-03-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Services Institute of Medical Sciences, Pakistan

    collaborator OTHER_GOV

  • Services Hospital, Lahore

    lead OTHER_GOV

Principal Investigators

  • Awais Amjad Malik, MBBS, FCPS · Services Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2025-12-31
Completion
2026-01-15

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07496216 on ClinicalTrials.gov