Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorÇanakkale Onsekiz Mart University

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Spasm-Controlled Lateral Internal Sphincterotomy
  • Lateral Internal Sphincterotomy up to Fissure Apex
  • Lateral Internal Sphincterotomy up to Dentate Line

Treatment groups

150 Participants
are divided into 3 treatment groups