Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula

Not Applicable

Completed

• Conditions: Anal Fistula
• Interventions: Procedure: Fistulotomy; Procedure: Marsupialization

• Registration Number: NCT03595839
• Lead Sponsor: Mansoura University

Brief Summary

Patients with simple anal fistula will undergo fistulotomy operation and will be divided into two groups: the first will undergo marsupialization of the laid open fistula track and second group will not undergo marsupialization. The effect of marsupialization on healing of anal fistula will be compared postoperatively.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2018-03-30
• Study Completion: 2018-07-01
• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-23
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Both genders
• Age: 18-65 years
• All Patients with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers).

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Exclusion Criteria

• High trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary.
• Recurrent anal fistulas.
• Patients associated with anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases and TB.
• High risk patients according to ASA (American society of anesthesiologists )
• Any degree of incontinence.
• Patients with previous anal surgery.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fistulotomy with Marsupialization	Marsupialization	Lay open and Marsupialization of the fistula track
Fistulotomy without Marsupialization	Fistulotomy	lay open of the fistula track
Fistulotomy with Marsupialization	Fistulotomy	Lay open and Marsupialization of the fistula track

Primary Outcome Measures

Name	Time	Method
Time to complete healing	8 weeks	The duration of time required to achieve complete wound healing

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt