Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07568314

Comparison of Botulinum Toxin Injection and Lateral Internal Sphincterotomy in Chronic Anal Fissure Management

Led by Islamabad Medical and Dental College · Updated on 2026-05-05

90

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to compare two commonly used treatments for chronic anal fissure: botulinum toxin injection and lateral internal sphincterotomy. Chronic anal fissure is a painful condition that causes severe discomfort during bowel movements and can significantly affect a patient's quality of life. Botulinum toxin injection is a minimally invasive procedure that temporarily relaxes the anal sphincter muscle to promote healing. In contrast, lateral internal sphincterotomy is a minor surgical procedure that permanently reduces sphincter pressure and is considered the standard treatment with high healing rates. A total of 90 adult patients with chronic anal fissure will be enrolled and divided into two groups. One group will receive botulinum toxin injection, while the other group will undergo lateral internal sphincterotomy. Patients will be followed up regularly to assess healing, pain relief, recurrence of the fissure, and any complications such as incontinence. The purpose of this study is to determine which treatment provides better outcomes in terms of effectiveness and safety, helping doctors choose the most appropriate treatment for patients.

CONDITIONS

Official Title

Comparison of Botulinum Toxin Injection and Lateral Internal Sphincterotomy in Chronic Anal Fissure Management

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years
  • Diagnosed chronic anal fissure lasting more than 6 weeks
  • Failure of conservative management for anal fissure
  • Both male and female patients
  • Willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Acute anal fissure
  • Previous anal surgery
  • Inflammatory bowel disease
  • Pregnancy
  • Neurological disorders affecting continence
  • Known hypersensitivity to botulinum toxin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Islamabad Medical and Dental College

Islamabad, Federal, Pakistan, 44000

Actively Recruiting

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Research Team

P

Prof.Dr Rizwan Aziz

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Comparison of Botulinum Toxin Injection and Lateral Internal Sphincterotomy in Chronic Anal Fissure Management | DecenTrialz