Actively Recruiting
A Comparative Study of Botulinum Toxin Injection Versus Lateral Internal Sphincterotomy for Chronic Anal Fissure Management
Led by Islamabad Medical and Dental College · Updated on 2026-05-05
90
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two common treatments for chronic anal fissure, a painful condition causing severe discomfort during bowel movements. The study evaluates botulinum toxin injection, a minimally invasive method that temporarily relaxes the anal muscle, and lateral internal sphincterotomy, a minor surgery that permanently reduces muscle pressure. The goal is to find which treatment offers better healing and safety for patients with this condition. Participants will be divided into two groups. One group will receive 20 units of botulinum toxin type A injected into the anal sphincter at two specific points using a fine needle. The other group will undergo lateral internal sphincterotomy, where a small surgical cut is made to divide part of the anal sphincter under spinal anesthesia. This procedure allows the wound to heal naturally. Both treatments aim to relieve symptoms and promote fissure healing. During the study, 90 adult patients will be regularly checked to assess how well the fissure heals within three months, relief from pain, recurrence rates, and any side effects like incontinence. Follow-up visits will monitor healing progress and complications. The study will help determine the effectiveness and safety of each treatment over time, supporting better treatment choices for chronic anal fissure.
CONDITIONS
Brief Title
Comparison of Botulinum Toxin Injection and Lateral Internal Sphincterotomy in Chronic Anal Fissure Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosed chronic anal fissure lasting more than 6 weeks
- Failure of conservative management
- Both male and female patients
- Willingness to provide informed consent
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single treatment with healing assessed over 3 months
Participants receive either an intrasphincteric injection of botulinum toxin type A or undergo a lateral internal sphincterotomy procedure to manage chronic anal fissure.
1 treatment visit with follow-up assessments over 3 months
Trial Site Locations
Total: 1 location
1
Islamabad Medical and Dental College
Islamabad, Federal, Pakistan, 44000
Actively Recruiting
Research Team
P
Prof.Dr Rizwan Aziz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here