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Completed
NCT07568314
Comparison of Botulinum Toxin Injection and Lateral Internal Sphincterotomy in Chronic Anal Fissure Management
Conditions: Anal Fissure Chronic
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Islamabad Medical and Dental College
Location: Islamabad Medical and Dental College Islamabad Federal
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 Criteria
Inclusion Criteria:
* Age 18-65 years
* Diagnosed chronic anal fissure (\>6 weeks duration)
* Failure of conservative management
* Both male and female patients
* Willingness to provide informed consent
Exclusion Criteria:
* Acute anal fissure
* Previous anal surgery
* Inflammatory bowel disease
* Pregnancy
* Neurological disorders affecting continence
* Known hypersensitivity to botulinum toxin
Source: ClinicalTrials.gov (NCT07568314). StuddyBuddy aggregates publicly available trial information.