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NCT01095900 Clinical Trial

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

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01095900
Other study ID # TheodorBRI
Secondary ID
Status Completed
Phase N/A
First received March 29, 2010
Last updated March 29, 2010

Study information
Verified date March 2010
Source Theodor Bilharz Research Institute
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• conservative lateral internal sphincterotomy

• Intra-sphincteric Botulinum-toxin injection

Locations
Country Name City State
Egypt Department of General Surgery-Theodore Bilharz Research Institute , Cairo

Sponsors (1)
Lead Sponsor Collaborator
Theodor Bilharz Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative pain relief, healing of fissure, continence scores 18 weeks Yes
Secondary fissure relapse 18 weeks Yes
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