Comparative Outcomes of Inj Botox Alone vs Inj Botox Combined With Fissurectomy and Anoplasty in the Management of Chronic Anal Fissure

Chronic anal fissure is a common benign anorectal condition characterized by severe pain during defecation, rectal bleeding, and reduced quality of life. Injection Botox is a widely used sphincter-preserving treatment that produces temporary relaxation of the internal anal sphincter and promotes fissure healing. However, healing rates with injection Botox alone are variable and recurrence remains a concern. This prospective comparative trial aims to compare the effectiveness and safety of injection Botox alone versus injection Botox combined with fissurectomy and anoplasty in adults with chronic anal fissure. The study will evaluate healing rate, pain relief, time to healing, recurrence, postoperative complications, continence outcomes, and patient satisfaction. A total of 108 eligible patients with chronic anal fissure will be enrolled and allocated to one of the two treatment groups. Participants will be followed after treatment to assess clinical outcomes. The results of this study are expected to provide evidence regarding the optimal sphincter-preserving treatment approach for chronic anal fissure and help improve patient care and quality of life.

NCT Number	NCT07665528
Lead Sponsor	Islamabad Medical and Dental College
Conditions	Anal Fissure Chronic
Enrollment	108 participants
Start Date	2026-06-03
Primary Completion	2026-09-03 (estimated)
Study Completion	2026-12-03 (estimated)
Updated on ClinicalTrials.gov	2026-06-26