Rerouting Seton Versus LIFT for Complex Anal Fistula

Not Applicable

• Conditions: Anal Fistula
• Interventions: Procedure: LIFT; Procedure: Rerouting seton

• Registration Number: NCT04616911
• Lead Sponsor: Mansoura University

Brief Summary

This study aims to compare the efficacy of two surgical techniques in treatment of complex anal fistulas. The first technique involves rerouting of the fistula tract with placement of a vessel loop seton around the internal anal sphincter, sparing the external sphincter whereas the second technique entails ligation of inter-sphincteric fistulous tract (LIFT). The main objectives of the study are to assess the success rate, time to healing, change in quality of life, and complications of each procedure including fecal incontinence.

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

• Status Verified: 2020-11
• Study Start: 2020-11-01
• Study First Submitted: 2020-11-01
• Study First Submitted QC: 2020-11-04
• Last Update Submitted: 2020-11-04
• Study First Posted: 2020-11-05
• Last Update Posted: 2020-11-05
• Primary Completion: 2021-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Adult patients of either sex with complex anal fistula including high trans-sphincteric, supra-sphincteric, extra-sphincteric, and anterior fistula in female

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Exclusion Criteria

• Patients with simple anal fistulas, including intersphicnteric and low trans-sphincteric fistulas.
• ASA IV and V (The American Society of Anesthesiologists Physical Status classification system) unfit patients
• Patient with any grade of anal incontinence.
• Patients with concomitant anal pathology.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIFT	LIFT	Ligation of the intersphincteric fistula tract
Rerouting seton	Rerouting seton	Placement of seton with rerouting of the fistula tract around the internal anal sphincter

Primary Outcome Measures

Name	Time	Method
Clinical Healing of anal fistula	12 months after surgery	Clinical healing is assessed by clinical examination during follow-up and is defined as Complete epithelization of the anal wound with no residual fistula tract or external opening or discharge

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt