Rerouting Seton Versus LIFT for Complex Anal Fistula

Mansoura University

Status: Unknown

Conditions: Anal Fistula

Treatments: Procedure: LIFT; Procedure: Rerouting seton

Study type: Interventional

Funder types: Other

Identifiers

NCT04616911

Mansoura2020M

Details and patient eligibility

About

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.

Enrollment: 77 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 2 patient groups

Rerouting seton

Active Comparator group

Description:

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

Treatment:

Procedure: Rerouting seton

LIFT

Active Comparator group

Description:

Ligation of the intersphincteric fistula tract

Treatment:

Procedure: LIFT