Closed Versus Open Lateral Internal Sphincterotomy for Chronic Anal Fissure

Services Hospital, Lahore160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Chronic Anal Fissure

Interventions

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.

Open Lateral Internal SphincterotomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Patients with complete wound healing

Defined as evidence of scarring at the fissure site

Time frame: 6 weeks

Anal incontinence

Wexner Continence Grading Scale

Time frame: 6 weeks

Secondary Outcomes

Pain score

Pain score through visual analog score

Time frame: 24 hours

Return to work in days

Time frame: 2 weeks

Recurrence

Reappearance of ulcer or tear in previously healed scar

Time frame: 1 year