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Rerouting Seton Versus LIFT for Complex Anal Fistula

NCT ID: NCT04616911

Last Updated: 2020-11-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-12-30

Brief Summary

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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

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Conditions

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Anal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Rerouting seton

Placement of seton with rerouting of the fistula tract around the internal anal sphincter

Group Type ACTIVE_COMPARATOR

Rerouting seton

Intervention Type PROCEDURE

Excision of superficial fistula tract and placment of seton with rerouting of the fistula tract around the internal anal sphincter

LIFT

Ligation of the intersphincteric fistula tract

Group Type ACTIVE_COMPARATOR

LIFT

Intervention Type PROCEDURE

Ligation of the intersphincteric fistula tract

Interventions

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Rerouting seton

Excision of superficial fistula tract and placment of seton with rerouting of the fistula tract around the internal anal sphincter

Intervention Type PROCEDURE

LIFT

Ligation of the intersphincteric fistula tract

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Associate professor of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh H Emile, M.D., FACS

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sameh H Emile, M.D., FACS

Role: CONTACT

[email protected]
+201006267150

Facility Contacts

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Sameh Emile, M.D

Role: primary

[email protected]
01006267150

Sameh H Emile, M.D.

Role: backup

Other Identifiers

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Mansoura2020M

Identifier Type: -

Identifier Source: org_study_id