Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07520552

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

On this page

AI-Summary

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

Eligible

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
Not Eligible

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

AI-Screening

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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)

Trial Site Locations

Total: 1 location

1

Canakkale Onsekiz Mart University

Çanakkale, Çanakkale, Turkey (Türkiye), 00017

Actively Recruiting

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Research Team

E

Emre Gülçek, MD, Assistant Professor

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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Published Research Related To This Trial

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.

Magdy M A Elsebae

https://pubmed.ncbi.nlm.nih.gov/17665247

Fine-tuning of the extent of lateral internal sphincterotomy: spasm-controlled vs. up to the fissure apex.

B Bülent Menteş, Melike Karen Güner, Sezai Leventoglu...

https://pubmed.ncbi.nlm.nih.gov/18085337