Ligation of Inter-sphincteric Fistula Tract for Management of Anal Fistula

NCT ID: NCT05314205

Last Updated: 2022-04-06

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

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-11-15

Brief Summary

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After abscess formation, an anal fistula is a common consequence, with crypto-glandular infection being the most commonly accepted causative cause. The goal of this study was to see how well closure of the inter-sphincteric fistula tract affects the outcome of trans-sphincteric fistula surgery. Patients with perianal trans-sphincteric fistulas who underwent ligation were studied prospectively. All patients had the identical anesthetic approach, followed by the operation with two years' follow-up.

Detailed Description

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Conditions

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Anal Fistula

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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ligation of inter-sphincteric fistula tract

The surgical treatment was achieved through identification of the fistula by injecting hydrogen peroxide (H2O2) through the external opening. Probing of the fistulous tract by a metallic probe for proper identification of the fistula in the inter-sphincteric plane.

Perpendicular skin incision (about 1 cm) was done at inter-sphinctric zone, perpendicular to the fistulous tract. Dissection between the internal and external sphincters and identification of the fistula.

Finally, Ligation and transection of the tract in inter-sphinctric space followed by excision of a segment and transferred for histopathology examination. Trans-fixation suture was applied near to the internal mucosal opening of the divided tract to confirm closure using polyglactin suture 2/0. Insertion of a probe to check the closure of the tract segments.

The remaining part of the tract was curetted till external opening and left for spontaneous healing.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Men and women with trans-sphincteric peri-anal fistulas (according to magnetic resonance fistulogram) of crypto-glandular source with no previous fistula surgery

Exclusion Criteria

* Individuals with recurrent fistulae or had specific pathology, like Crohn's disease.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Abdulkarim Hasan

Laboratory coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Abdulkarim Hasan

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AUHS2101201

Identifier Type: -

Identifier Source: org_study_id

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