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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01095900
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : March 30, 2010
Information provided by:
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.

Condition or disease Intervention/treatment
Pain Procedure: conservative lateral internal sphincterotomy Procedure: Intra-sphincteric Botulinum-toxin injection

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective

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

Primary Outcome Measures :
  1. Postoperative pain relief, healing of fissure, continence scores [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. fissure relapse [ Time Frame: 18 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This trial included consecutive adult patients presenting with symptomatic chronic anal fissure in which conservative treatment had failed.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01095900

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Department of General Surgery-Theodore Bilharz Research Institute ,
Cairo, Egypt
Sponsors and Collaborators
Theodor Bilharz Research Institute
Layout table for additonal information Identifier: NCT01095900    
Other Study ID Numbers: TheodorBRI
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: March 30, 2010
Last Verified: March 2010
Keywords provided by Theodor Bilharz Research Institute:
Pain after treatment
healing of fissure after treatment
continence scores after treatment
Additional relevant MeSH terms:
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Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs