Anal Fissure Clinical Trials

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A Prospective Randomized Controlled Trial Comparing Spasm-Controlled, Fissure Apex-Limited, and Dentate Line-Limited Lateral Internal Sphincterotomy Techniques in Chronic Anal Fissure

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Canakkale Onsekiz Mart University
RECRUITING
Çanakkale
Contact Information
Primary
Emre Gülçek, MD, Assistant Professor
emre.gulcek@comu.edu.tr
+905544810964
Time Frame
Start Date: 2026-05-06
Estimated Completion Date: 2028-05-06
Participants
Target number of participants: 150
Treatments
Active_comparator: Spasm-Controlled LIS
Serial small open sphincterotomies performed under local anesthesia plus IV sedation. Anal caliber is measured with an anal calibrator before and after each increment until a caliber of 30 mm is achieved.
Active_comparator: LIS up to Fissure Apex
Open lateral internal sphincterotomy extended to the proximal end of the fissure (fissure apex) under spinal or general anesthesia. The length of sphincterotomy equals the length of the fissure.
Active_comparator: LIS up to Dentate Line
Open lateral internal sphincterotomy extended to the level of the dentate line under spinal or general anesthesia. This is the traditional (classical) LIS technique.
Sponsors
Leads: Çanakkale Onsekiz Mart University

This content was sourced from clinicaltrials.gov