Ligation of Intersphincteric Fistula Tract Versus Rectal Advancement Flap in the Treatment of Complex Anal Fistula: Randomised Clinical Trial

Status: Active, not recruiting
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3

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.

Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No

• patient diagnosed with transsphincteric (medium or high) or suprasphincteric cryptoglandular anal fistula

• with no abscess at the time of surgery

• who agreed to participate and signed the informed consent form

• capable transsphincteric understanding and following study instructions

Time Frame
Start Date: January 1, 2013
Estimated Completion Date: January 1, 2023
Target number of participants: 72
Experimental: LIFT
ligation of interesphincteric fistula tract
Active Comparator: FLAP
Rectal advancement flap
Jorge Alejandro Benavides Buleje
Related Therapeutic Areas
Leads: Hospital General Universitario Reina Sofía de Murcia

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