Anal Fissure Clinical Trials

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A Prospective Comparative Study of Clinical Outcomes Between Botulinum Toxin Injection and Lateral Internal Sphincterotomy in the Management of Chronic Anal Fissure

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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Locations
Other Locations
Pakistan
Islamabad Medical and Dental College
RECRUITING
Islamabad
Contact Information
Primary
Prof.Dr Rizwan Aziz
aziz.rizwan@imdcollege.edu.pk
+923008444229
Time Frame
Start Date: 2026-03-02
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 90
Treatments
Experimental: Botulinum Toxin Injection
Participants in this arm will receive an intrasphincteric injection of 20 units of botulinum toxin type A. The toxin will be diluted in 1 ml of normal saline and administered as two injections of 10 units each at the 3 o'clock and 9 o'clock positions in the intersphincteric plane under aseptic conditions using a 26-30 gauge needle.
Active_comparator: Lateral Internal Sphincterotomy
Participants in this arm will undergo open lateral internal sphincterotomy under spinal anesthesia. A small incision will be made at the lateral position (3 o'clock), and the lower one-third of the internal anal sphincter will be divided under direct vision. Hemostasis will be secured, and the wound will be left open for secondary healing
Related Therapeutic Areas
Sponsors
Leads: Islamabad Medical and Dental College

This content was sourced from clinicaltrials.gov