Comparison of Botulinum Toxin and Sphincterotomy in the Treatment of Chronic Anal Fissure

Completed

• Conditions: Pain
• Interventions: Procedure: conservative lateral internal sphincterotomy; Procedure: Intra-sphincteric Botulinum-toxin injection

• Registration Number: NCT01095900
• Lead Sponsor: Theodor Bilharz Research Institute

Brief Summary

Intra-sphincteric injection of botulinum toxin seems to be a reliable option causing temporary alleviation of sphincter spasm and allowing the fissure to heal. study is to compare the outcome of surgical sphincterotomy and botulinum toxin injection treatments in patients with uncomplicated chronic anal fissure.

Detailed Description

consecutive patients with uncomplicated chronic anal fissure who had failed conservative treatment were randomized to receive either intra-sphincteric injection of botulinum toxin (BT) or lateral internal sphincterotomy (LIS). Postoperative pain relief, healing of fissure, continence scores and fissure relapse during 18 weeks of follow up was the outcomes assessed.

Study Timeline

• Status Verified: 2010-03
• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-03-29
• Last Update Submitted: 2010-03-29
• Study First Posted: 2010-03-30
• Last Update Posted: 2010-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• The diagnosis of chronic anal fissure was based on evidence of circumscribed ulcer at anal canal with indurations at the edges and exposure of the horizontal fibers of the internal anal sphincter at its floor.

Exclusion Criteria

• Anal fissure that had been operated on before, complicated fissure with cicatricial deformation, large sentinel pile, associated hemorrhoids, suspected inflammatory bowel disease, or malignancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LIS group)	conservative lateral internal sphincterotomy	-
BT group	Intra-sphincteric Botulinum-toxin injection	-

Primary Outcome Measures

Name	Time	Method
Postoperative pain relief, healing of fissure, continence scores	18 weeks

Secondary Outcome Measures

Name	Time	Method
fissure relapse	18 weeks

Trial Locations

Locations (1)

Department of General Surgery-Theodore Bilharz Research Institute ,; 🇪🇬 Cairo, Egypt