Three LIS techniques for chronic anal fissure healing
Official title: A Prospective Randomized Controlled Trial Comparing Spasm-Controlled, Fissure Apex-Limited, and Dentate Line-Limited Lateral Internal Sphincterotomy Techniques in Chronic Anal Fissure
Run by Çanakkale Onsekiz Mart University · NCT07520552 · Data updated 2026-11-12
This trial tests three different ways of performing lateral internal sphincterotomy to see which best heals chronic anal fissures with the least risk of incontinence.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Çanakkale Onsekiz Mart University Academic / other |
| Locations | 1 site (Çanakkale, Çanakkale) |
| Status | Recruiting |
| Started | May 6, 2026 |
| Main results expected | May 6, 2027 |
| Study ends | May 6, 2028 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07520552 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older with chronic anal fissure unhealed after at least 6 weeks of medical therapy and no baseline incontinence (Wexner score = 0).
✕Probably not a fit
Patients with preexisting anal incontinence, active anorectal infection, or conditions increasing surgical risk may derive less or no benefit and could be excluded or experience harms.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized study enrolling 150 adults with chronic anal fissure that did not heal with medical therapy. Participants are assigned equally to three LIS techniques: spasm-controlled LIS with small staged cuts under local anesthesia, LIS extended to the fissure apex under spinal or general anesthesia, and LIS extended to the dentate line under spinal or general anesthesia. Primary outcomes are fissure healing and new fecal incontinence at 12 months, measured by the Wexner score; secondary outcomes include postoperative pain, recurrence, patient satisfaction, and complications. The trial aims to determine which technique balances healing efficacy with continence preservation. It is conducted at Çanakkale Onsekiz Mart University with a single center’s involvement.
Why it matters
Potential benefit: If successful, the study could identify a LIS technique that maintains high healing rates while reducing the risk of postoperative incontinence.
How similar studies have gone: Prior smaller studies suggested differences in continence and healing among LIS approaches, but no randomized trial directly compared all three techniques simultaneously.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Canakkale Onsekiz Mart University
Çanakkale, Çanakkale, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Emre Gülçek, MD, Assistant Professor
- Email: emre.gulcek@comu.edu.tr
- Phone: +905544810964
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.