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Ligation of Intersphincteric Fistula Tract Versus Rectal Advancement Flap in the Treatment of Complex Anal Fistula

NCT05263661 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-03-02

No results posted yet for this study

Summary

Objective: Rectal advancement flap (RAF) is currently considered the gold standard in the treatment of complex anal fistula (CAF). Clinical trials are a priority given the few consistent results available with level 1 evidence. We compare the results of two conservative sphincter techniques: ligation of intersphincteric fistula tract (LIFT) versus RAF.

Material and Method: A controlled, randomised clinical trial is conducted in patients operated between 2013 and 2016 in Hospital General Universitario Reina Sofia, Murcia, Spain. The primary objective was to evaluate relapse at 12 months of follow-up, and the secondary objectives were post-op anal continence (Wexner), post-operative complications (haematoma, infection of surgical site, suture dehiscence), duration of surgery and hospitalisation. Post-operative controls 1, 3, 6 and 12 months after surgery.

Conditions

  • Anal Fistula

Interventions

PROCEDURE

LIFT

Ligation of fistula tract between external and internal sphincter

PROCEDURE

FLAP

Creation of a partial wall rectal flap to close internal opening of fistula tract

Sponsors & Collaborators

  • Hospital General Universitario Reina Sofía de Murcia

    lead OTHER

Principal Investigators

  • Jorge Alejandro Benavides Buleje, PhD · Hospital General Universitario Reina Sofía

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2014-01-01
Completion
2023-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05263661 on ClinicalTrials.gov