Closed Versus Open Lateral Internal Sphincterotomy for Chronic Anal Fissure

NCT07496216 | Completed DMC

• 1 other identifier: RCT30SIMS
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic Anal Fissure, Lateral Internal Sphincterotomy, Closed Technique, Open Technique, Wound Healing

Outcome Measures

Primary Outcomes (2)

• Number of Patients with complete wound healing

  Defined as evidence of scarring at the fissure site

  6 weeks

• Anal incontinence

  Wexner Continence Grading Scale

  6 weeks

Secondary Outcomes (3)

• Pain score

  24 hours

• Return to work in days

  2 weeks

• Recurrence

  1 year

Study Arms (2)

Group A-CLIS

ACTIVE COMPARATOR

Closed Lateral Internal Sphincterotomy (CLIS) under spinal anesthesia

Procedure: Closed Lateral Internal Sphincterotomy

Group B-OLIS

ACTIVE COMPARATOR

Open Lateral Internal Sphincterotomy (OLIS) under spinal anesthesia

Procedure: Open Lateral Internal Sphincterotomy

Interventions

Closed Lateral Internal Sphincterotomy PROCEDURE

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.

Group A-CLIS

Open Lateral Internal Sphincterotomy PROCEDURE

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.

Group B-OLIS

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Services Hospital, Lahore: lead
• Services Institute of Medical Sciences, Pakistan: collaborator

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

Study Officials

• Awais Amjad Malik, MBBS, FCPS

  Services Institute of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: February 1, 2019
• Primary Completion: December 31, 2025
• Study Completion: January 15, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)