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

March 29, 2010 updated by: Theodor Bilharz Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Department of General Surgery-Theodore Bilharz Research Institute ,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This trial included consecutive adult patients presenting with symptomatic chronic anal fissure in which conservative treatment had failed.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LIS group)
Procedure: conservative lateral internal sphincterotomy
BT group
Procedure: Intra-sphincteric Botulinum-toxin injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain relief, healing of fissure, continence scores
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
fissure relapse
Time Frame: 18 weeks
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theodor Bilharz Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (ESTIMATE)

March 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 30, 2010

Last Update Submitted That Met QC Criteria

March 29, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TheodorBRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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