A Prospective Randomized Controlled Trial Comparing Three 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
52 weeks
Total Duration
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What this Trial Is About
Researchers are evaluating three different surgical techniques of lateral internal sphincterotomy (LIS) for patients with chronic anal fissure that has not improved with medical treatment. The study aims to compare the healing rates and the occurrence of fecal incontinence among these techniques over 12 months. This trial is a prospective randomized controlled study involving 150 adult patients, assessing how different extents of sphincterotomy affect outcomes.
The three techniques being compared are Spasm-Controlled LIS, which uses serial small sphincterotomies under local anesthesia and sedation until a target anal canal size is reached; LIS up to the Fissure Apex, an open procedure under spinal or general anesthesia extending to the fissure's end; and LIS up to the Dentate Line, the traditional open method extending to the dentate line, also under spinal or general anesthesia. Randomization assigns patients equally to one of these groups, and all surgeries are performed with an open technique in the lithotomy position.
Participants will be evaluated before surgery and at several points after surgery including day 1, weeks 1 and 2, and months 1, 2, 6, and 12. Researchers will use the Wexner Incontinence Score to assess continence and will check for fissure healing, pain levels, recurrence, patient satisfaction, and complications. The study includes careful monitoring to compare the effectiveness and safety of the different surgical approaches over a full year.
CONDITIONS
Brief Title
Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Age 18 years or older
Diagnosis of chronic anal fissure lasting 8 weeks or more
Failed healing after at least 6 weeks of medical treatment including topical agents, fiber supplementation, or sitz baths
Complete fecal continence before surgery (Wexner Incontinence Score = 0)
Primary anal fissure located at posterior or anterior midline
Provided written informed consent
You will not qualify if you...
Any degree of fecal incontinence before surgery
Secondary anal fissure related to Crohn's disease, tuberculosis, HIV, syphilis, or other systemic conditions
Previous anal sphincter surgery
History of obstetric sphincter injury
Active anorectal infection such as abscess or fistula
Pregnancy or breastfeeding
Uncorrectable bleeding disorders or current use of anticoagulants
Unable to cooperate with study procedures or attend follow-up visits
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 1 day
Participants undergo one of three lateral internal sphincterotomy surgical techniques to treat chronic anal fissure.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 12 months
Participants are monitored for healing, pain relief, continence, and complications after surgery.
7 follow-up visits at Day 1, Week 1, Week 2, Month 1, Month 2, Month 6, and Month 12 (in-person)
A study of fecal incontinence in patients with chronic anal fissure: prospective, randomized, controlled trial of the extent of internal anal sphincter division during lateral sphincterotomy.