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Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure

NCT07520552 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-14

No results posted yet for this study

Summary

This prospective randomized controlled trial compares three lateral internal sphincterotomy (LIS) techniques in patients with chronic anal fissure refractory to medical treatment: (1) Spasm-Controlled LIS (serial small sphincterotomies using an anal calibrator until 30 mm anal caliber is achieved, under local anesthesia plus sedation), (2) LIS up to the Fissure Apex (spinal or general anesthesia), and (3) LIS up to the Dentate Line (spinal or general anesthesia). The primary outcomes are fissure healing rate and fecal incontinence incidence at 12 months, assessed using the Wexner Incontinence Score. Secondary outcomes include postoperative pain (VAS), recurrence rate, patient satisfaction, and complications. A total of 150 patients (50 per group) will be enrolled and followed for 12 months.

Conditions

  • Chronic Anal Fissure

Interventions

PROCEDURE

Spasm-Controlled Lateral Internal Sphincterotomy

Serial small open sphincterotomies under local anesthesia plus IV sedation using an anal calibrator until anal caliber of 30 mm is achieved.

PROCEDURE

Lateral Internal Sphincterotomy up to Fissure Apex

Open LIS extended to the proximal end of the fissure under spinal or general anesthesia.

PROCEDURE

Lateral Internal Sphincterotomy up to Dentate Line

Open LIS extended to the level of the dentate line under spinal or general anesthesia.

Sponsors & Collaborators

  • Çanakkale Onsekiz Mart University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2027-05-06
Completion
2028-05-06

Countries

  • Turkey (Türkiye)

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 NCT07520552 on ClinicalTrials.gov