Actively Recruiting
Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure
Led by Çanakkale Onsekiz Mart University · Updated on 2026-05-14
150
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of chronic anal fissure lasting 8 weeks or more
- Failure to heal after at least 6 weeks of medical treatment (topical agents, fiber supplementation, sitz baths)
- Complete fecal continence before surgery (Wexner Incontinence Score = 0)
- Primary anal fissure located at posterior or anterior midline
- Signed informed consent provided
You will not qualify if you...
- Any level of fecal incontinence before surgery
- Secondary anal fissure caused by Crohn's disease, tuberculosis, HIV, syphilis, or other systemic conditions
- Previous anal sphincter surgery
- History of obstetric sphincter injury
- Current anorectal infection such as abscess or fistula
- Pregnancy or breastfeeding
- Uncorrectable blood clotting problems or current use of anticoagulant medications
- Inability to cooperate with study procedures or attend follow-up visits
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Canakkale Onsekiz Mart University
Çanakkale, Çanakkale, Turkey (Türkiye), 00017
Actively Recruiting
Research Team
E
Emre Gülçek, MD, Assistant Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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