Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure

Recruiting now · Not applicable

Conditions studied: Chronic Anal Fissure

In brief

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.

Key facts

Study ID

NCT07520552

Run by

Çanakkale Onsekiz Mart University

People needed

150

Starts

2026-05-06

Expected to finish

2028-05-06

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Diagnosis of chronic anal fissure (duration ≥8 weeks)
• Failure to heal after at least 6 weeks of appropriate medical treatment (topical agents, fiber supplementation, sitz baths)
• Complete preoperative fecal continence (Wexner Incontinence Score = 0)
• Primary anal fissure (posterior or anterior midline location)
• Written informed consent

You may not qualify if…

• Any degree of preoperative fecal incontinence
• Secondary anal fissure (associated with Crohn's disease, tuberculosis, HIV, syphilis, or other systemic conditions)
• Previous anal sphincter surgery
• History of obstetric sphincter injury
• Active anorectal infection (abscess or fistula)
• Pregnancy or breastfeeding
• Uncorrectable coagulopathy or current anticoagulant use
• Inability to cooperate with study procedures or attend follow-up visits

Where it is running

• Canakkale Onsekiz Mart University — Çanakkale, Çanakkale, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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