Multimodal treatment of perianal fistulas in Crohn's disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial.
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de Groof E Joline, Buskens Christianne J, Ponsioen Cyriel Y, Dijkgraaf Marcel G W, D'Haens Geert R A M, Srivastava Nidhi, van Acker Gijs J D, Jansen Jeroen M, Gerhards Michael F, Dijkstra Gerard, Lange Johan F M, Witteman Ben J M, Kruyt Philip M, Pronk Apollo, van Tuyl Sebastiaan A C, Bodelier Alexander, Crolla Rogier M P H, West Rachel L, Vrijland Wietske W, Consten Esther C J, Brink Menno A, Tuynman Jurriaan B, de Boer Nanne K H, Breukink Stephanie O, Pierik Marieke J, Oldenburg Bas, van der Meulen Andrea E, Bonsing Bert A, Spinelli Antonino, Danese Silvio, Sacchi Matteo, Warusavitarne Janindra, Hart Ailsa, Yassin Nuha A, Kennelly Rory P, Cullen Garret J, Winter Desmond C, Hawthorne A Barney, Torkington Jared, Bemelman Willem A
Аннотация
METHODS/DESIGN: This is a multicentre, randomized controlled trial. Patients with Crohn's disease who are over 18 years of age, with newly diagnosed or recurrent active high perianal fistulas, with one internal opening and no anti-TNF usage in the past three months will be considered. Patients with proctitis, recto-vaginal fistulas or anal stenosis will be excluded. Prior to randomisation, an MRI and ileocolonoscopy are required. All treatment will start with seton placement and a course of antibiotics. Patients will then be randomised to: (1) chronic seton drainage (with oral 6-mercaptopurine (6MP)) for one year, (2) anti-TNF medication (with 6MP) for one year (seton removal after six weeks) or (3) advancement plasty after eight weeks of seton drainage (under four months anti-TNF and 6MP for one year). The primary outcome parameter is the number of patients needing fistula-related re-intervention(s). Secondary outcomes are the number of patients with closed fistulas (based on an evaluated MRI score) after 18 months, disease activity, quality of life and costs.
DISCUSSION: The PISA trial is a multicentre, randomised controlled trial of patients with Crohn's disease and high perianal fistulas. With the comparison of three generally accepted treatment strategies, we will be able to comment on the efficiency of the various treatment strategies, with respect to several long-term outcome parameters.
TRIAL REGISTRATION: Nederlands Trial Register identifier: NTR4137 (registered on 23 August 2013).