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Completed

NCT Number: NCT01095900

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of General Surgery-Theodore Bilharz Research Institute ,

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

conservative lateral internal sphincterotomy

Procedure

Intra-sphincteric Botulinum-toxin injection

Procedure

Primary outcomes

  1. Postoperative pain relief, healing of fissure, continence scores

    Time frame: 18 weeks

Secondary outcomes

  1. fissure relapse

    Time frame: 18 weeks

Sponsors and collaborators

Lead sponsor

Theodor Bilharz Research Institute

Other

Registry information

Important dates

First posted
Mar 30, 2010
Registry last updated
Mar 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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