Rerouting Seton Versus LIFT for Complex Anal Fistula

Anal Fistula Clinical Trial

Official title:

External Anal Sphincter-Sparing Seton After Rerouting Versus Ligation of Intersphincteric Fistula Tract (LIFT) In Treatment Of Complex Anal Fistula: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04616911
• Other study ID #: Mansoura2020M
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2020
• Source: Mansoura University
• Contact: Sameh H Emile, M.D., FACS
• Phone: +201006267150
• Email: sameh200[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• Rerouting seton
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

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Healing of anal fistula	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	12 months after surgery