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

NCT ID: NCT01095900

Last Updated: 2010-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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

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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.

Conditions

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Pain

Keywords

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Pain after treatment healing of fissure after treatment continence scores after treatment

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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LIS group)

conservative lateral internal sphincterotomy

Intervention Type PROCEDURE

BT group

Intra-sphincteric Botulinum-toxin injection

Intervention Type PROCEDURE

Interventions

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conservative lateral internal sphincterotomy

Intervention Type PROCEDURE

Intra-sphincteric Botulinum-toxin injection

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Theodor Bilharz Research Institute

OTHER

Sponsor Role lead

Locations

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Department of General Surgery-Theodore Bilharz Research Institute ,

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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TheodorBRI

Identifier Type: -

Identifier Source: org_study_id