UnknownPhase 3

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

72 participantsStarted 2013-01-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * diagnosed with, or with a suspected diagnosis of, Crohn's disease * diagnosed with, or with a suspected diagnosis of, malignant anal tumour * diagnosed with, or with a suspected diagnosis of,tuberculosis or suppurative hidradenitis * a history of radiotherapy of the ano-perineal region * language difficulties that prevent comprehension of the study * refusal to participate

What they're measuring

Curation

Timeframe: 1 year

Trial details

NCT IDNCT05263661

SponsorHospital General Universitario Reina Sofía de Murcia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-01-01