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Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure

RecruitingNAAges 18 Years - anyAllÇanakkale Onsekiz Mart University
NCT07520552 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

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

1 site
Canakkale Onsekiz Mart University
Çanakkale, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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