TY - JOUR
T1 - Multimodal treatment of perianal fistulas in Crohn's disease
T2 - Seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial
AU - de Groof, E. Joline
AU - Buskens, Christianne J.
AU - Ponsioen, Cyriel Y.
AU - Dijkgraaf, Marcel G. W.
AU - D'Haens, Geert R. A. M.
AU - Srivastava, Nidhi
AU - van Acker, Gijs J. D.
AU - Jansen, Jeroen M.
AU - Gerhards, Michael F.
AU - Dijkstra, Gerard
AU - Lange, Johan F. M.
AU - Witteman, Ben J. M.
AU - Kruyt, Philip M.
AU - Pronk, Apollo
AU - van Tuyl, Sebastiaan A. C.
AU - Bodelier, Alexander
AU - Crolla, Rogier M. P. H.
AU - West, Rachel L.
AU - Vrijland, Wietske W.
AU - Consten, Esther C. J.
AU - Brink, Menno A.
AU - Tuynman, Jurriaan B.
AU - de Boer, Nanne K. H.
AU - Breukink, Stephanie O.
AU - Pierik, Marieke J.
AU - Oldenburg, Bas
AU - van der Meulen, Andrea E.
AU - Bonsing, Bert A.
AU - Spinelli, Antonino
AU - Danese, Silvio
AU - Sacchi, Matteo
AU - Warusavitarne, Janindra
AU - Hart, Ailsa
AU - Yassin, Nuha A.
AU - Kennelly, Rory P.
AU - Cullen, Garret J.
AU - Winter, Desmond C.
AU - Hawthorne, A. Barney
AU - Torkington, Jared
AU - Bemelman, Willem A.
PY - 2015/8/20
Y1 - 2015/8/20
N2 - Background: Currently there is no guideline for the treatment of patients with Crohn's disease and high perianal fistulas. Most patients receive anti-TNF medication, but no long-term results of this expensive medication have been described, nor has its efficiency been compared to surgical strategies. With this study, we hope to provide treatment consensus for daily clinical practice with reduction in costs.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.
AB - Background: Currently there is no guideline for the treatment of patients with Crohn's disease and high perianal fistulas. Most patients receive anti-TNF medication, but no long-term results of this expensive medication have been described, nor has its efficiency been compared to surgical strategies. With this study, we hope to provide treatment consensus for daily clinical practice with reduction in costs.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.
KW - Crohn's disease
KW - Perianal fistula
KW - Seton
KW - Anti-TNF
KW - Advancement plasty
KW - Quality of life
KW - Cost-effectiveness
KW - QUALITY-OF-LIFE
KW - ANAL FISTULAS
KW - IN-ANO
KW - INFLIXIMAB
KW - THERAPY
KW - SURGERY
KW - EXPERIENCE
KW - OUTCOMES
KW - SAFETY
U2 - 10.1186/s13063-015-0831-x
DO - 10.1186/s13063-015-0831-x
M3 - Article
SN - 1745-6215
VL - 16
JO - Trials
JF - Trials
M1 - 366
ER -