NCT07520552 Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure
| NCT ID | NCT07520552 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Çanakkale Onsekiz Mart University |
| Condition | Chronic Anal Fissure |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-05-06 |
| Primary Completion | 2027-05-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-05-06 with a primary completion date of 2027-05-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07520552 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Anal Fissure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07520552 currently recruiting?
Yes, NCT07520552 is actively recruiting participants. Contact the research team at emre.gulcek@comu.edu.tr for enrollment information.
Where is the NCT07520552 trial being conducted?
This trial is being conducted at Çanakkale, Turkey (Türkiye).
Who is sponsoring the NCT07520552 clinical trial?
NCT07520552 is sponsored by Çanakkale Onsekiz Mart University. The trial plans to enroll 150 participants.