A Multicenter Randomized Controlled Trial Comparing Safety, Efficacy, and Cost-effectiveness of the Surgisis Anal Fistula Plug Versus Surgeon's Preference for Transsphincteric Fistula-in-Ano: The FIAT Trial.

Annals of Surgery
David G JayneFIAT Trial Collaborative Group

Abstract

To undertake a randomized comparison of the Biodesign Surgisis anal fistula plug against surgeon's preference in treating cryptoglandular transsphincteric fistula-in-ano. The efficacy of the Biodesign Surgisis anal fistula plug in healing anal fistulae is uncertain. Participants were randomized to the fistula plug with surgeon's preference (advancement flap, cutting seton, fistulotomy, Ligation of the Intersphincteric Fistula Tract procedure). The primary outcome was faecal incontinence quality of life (FIQoL) at 12-months. Secondary outcomes were fistula healing, incontinence rates, and complication and reintervention rates. Between May 2011 and March 2016, 304 participants were randomized to fistula plug or surgeon's preference. No differences were seen in FIQoL between the 2 groups at 12 months. Clinical fistula healing was reported in 66/122 (54%) of the fistula plug and 66/119 (55%) of the surgeon's preference groups at 12 months. Fecal incontinence rates improved marginally in both the groups. Complications and reinterventions were frequent, with significantly more complications in the fistula plug group at 6-weeks (49/142, 35% vs 25/137, 18%; P=0.002). The mean total costs were £2738 (s.d. £1151) for the fistula plug and...Continue Reading

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Citations

Sep 9, 2020·Colorectal Disease : the Official Journal of the Association of Coloproctology of Great Britain and Ireland·P Garg
Nov 19, 2020·Clinical and Experimental Gastroenterology·Pankaj GargNavdeep Garg
Mar 12, 2021·Journal of Gastrointestinal Surgery : Official Journal of the Society for Surgery of the Alimentary Tract·Pankaj Garg, Vipul D Yagnik
Feb 3, 2021·Colorectal Disease : the Official Journal of the Association of Coloproctology of Great Britain and Ireland·Pankaj GargGeetha R Menon
May 11, 2021·World Journal of Gastrointestinal Surgery·Pankaj GargGeetha R Menon
May 7, 2021·Colorectal Disease : the Official Journal of the Association of Coloproctology of Great Britain and Ireland·Paul F VollebregtRichelle J F Felt-Bersma
Jul 28, 2021·Journal of Laparoendoscopic & Advanced Surgical Techniques. Part a·Karina E Pedersen, Amy L Lightner
Oct 13, 2021·Current Opinion in Gastroenterology·Melissa M Alvarez-Downing, Giovanna da Silva

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