Multimodal treatment of perianal fistulas in Crohn's disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial

E.J. de Groof; C.J. Buskens; C. Y. Ponsioen; M.G. Dijkgraaf; G.R. D'Haens; N. Srivastava; G.J. van Acker; J.M. Jansen; M.F. Gerhards; G. Dijkstra; J.F. Lange; B.J. Witteman; P.M. Kruyt; A. Pronk; S.A. van Tuyl; A. Bodelier; R. M. Crolla; R.L. West; W.W. Vrijland; E.C. Consten; M.A. Brink; J.B. Tuynman; N.K. de Boer; S. Breukink; M. Pierik; B. Oldenburg; A.E. van der Meulen; B.A. Bonsing; A. Spinelli; S. Danese; M. Sacchi; J. Warusavitarne; A. Hart; N.A. Yassin; R.P. Kennelly; G.J. Cullen; D.C. Winter; A.B. Hawthorne; J. Torkington; W.A. Bemelman

doi:10.1186/s13063-015-0831-x

Multimodal treatment of perianal fistulas in Crohn's disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial

E.J. de Groof, C.J. Buskens, C. Y. Ponsioen, M.G. Dijkgraaf, G.R. D'Haens, N. Srivastava, G.J. van Acker, J.M. Jansen, M.F. Gerhards, G. Dijkstra, J.F. Lange, B.J. Witteman, P.M. Kruyt, A. Pronk, S.A. van Tuyl, A. Bodelier, R. M. Crolla, R.L. West, W.W. Vrijland, E.C. ConstenM.A. Brink, J.B. Tuynman, N.K. de Boer, S. Breukink, M. Pierik, B. Oldenburg, A.E. van der Meulen, B.A. Bonsing, A. Spinelli, S. Danese, M. Sacchi, J. Warusavitarne, A. Hart, N.A. Yassin, R.P. Kennelly, G.J. Cullen, D.C. Winter, A.B. Hawthorne, J. Torkington, W.A. Bemelman^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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. TRIAL REGISTRATION: Nederlands Trial Register identifier: NTR4137 (registered on 23 August 2013).

Original language	English
Article number	366
Journal	Trials
Volume	16
Issue number	1
DOIs	https://doi.org/10.1186/s13063-015-0831-x
Publication status	Published - 1 Jan 2015

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de Groof, E. J., Buskens, C. J., Ponsioen, C. Y., Dijkgraaf, M. G., D'Haens, G. R., Srivastava, N., van Acker, G. J., Jansen, J. M., Gerhards, M. F., Dijkstra, G., Lange, J. F., Witteman, B. J., Kruyt, P. M., Pronk, A., van Tuyl, S. A., Bodelier, A., Crolla, R. M., West, R. L., Vrijland, W. W., ... Bemelman, W. A. (2015). Multimodal treatment of perianal fistulas in Crohn's disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial. Trials, 16(1), Article 366. https://doi.org/10.1186/s13063-015-0831-x

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title = "Multimodal treatment of perianal fistulas in Crohn's disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial",

abstract = "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. TRIAL REGISTRATION: Nederlands Trial Register identifier: NTR4137 (registered on 23 August 2013).",

author = "{de Groof}, E.J. and C.J. Buskens and Ponsioen, {C. Y.} and M.G. Dijkgraaf and G.R. D'Haens and N. Srivastava and {van Acker}, G.J. and J.M. Jansen and M.F. Gerhards and G. Dijkstra and J.F. Lange and B.J. Witteman and P.M. Kruyt and A. Pronk and {van Tuyl}, S.A. and A. Bodelier and Crolla, {R. M.} and R.L. West and W.W. Vrijland and E.C. Consten and M.A. Brink and J.B. Tuynman and {de Boer}, N.K. and S. Breukink and M. Pierik and B. Oldenburg and {van der Meulen}, A.E. and B.A. Bonsing and A. Spinelli and S. Danese and M. Sacchi and J. Warusavitarne and A. Hart and N.A. Yassin and R.P. Kennelly and G.J. Cullen and D.C. Winter and A.B. Hawthorne and J. Torkington and W.A. Bemelman",

year = "2015",

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day = "1",

doi = "10.1186/s13063-015-0831-x",

language = "English",

volume = "16",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd",

number = "1",

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de Groof, EJ, Buskens, CJ, Ponsioen, CY, Dijkgraaf, MG, D'Haens, GR, Srivastava, N, van Acker, GJ, Jansen, JM, Gerhards, MF, Dijkstra, G, Lange, JF, Witteman, BJ, Kruyt, PM, Pronk, A, van Tuyl, SA, Bodelier, A, Crolla, RM, West, RL, Vrijland, WW, Consten, EC, Brink, MA, Tuynman, JB, de Boer, NK, Breukink, S , Pierik, M, Oldenburg, B, van der Meulen, AE, Bonsing, BA, Spinelli, A, Danese, S, Sacchi, M, Warusavitarne, J, Hart, A, Yassin, NA, Kennelly, RP, Cullen, GJ, Winter, DC, Hawthorne, AB, Torkington, J & Bemelman, WA 2015, 'Multimodal treatment of perianal fistulas in Crohn's disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial', Trials, vol. 16, no. 1, 366. https://doi.org/10.1186/s13063-015-0831-x

TY - JOUR

T1 - Multimodal treatment of perianal fistulas in Crohn's disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial

AU - de Groof, E.J.

AU - Buskens, C.J.

AU - Ponsioen, C. Y.

AU - Dijkgraaf, M.G.

AU - D'Haens, G.R.

AU - Srivastava, N.

AU - van Acker, G.J.

AU - Jansen, J.M.

AU - Gerhards, M.F.

AU - Dijkstra, G.

AU - Lange, J.F.

AU - Witteman, B.J.

AU - Kruyt, P.M.

AU - Pronk, A.

AU - van Tuyl, S.A.

AU - Bodelier, A.

AU - Crolla, R. M.

AU - West, R.L.

AU - Vrijland, W.W.

AU - Consten, E.C.

AU - Brink, M.A.

AU - Tuynman, J.B.

AU - de Boer, N.K.

AU - Breukink, S.

AU - Pierik, M.

AU - Oldenburg, B.

AU - van der Meulen, A.E.

AU - Bonsing, B.A.

AU - Spinelli, A.

AU - Danese, S.

AU - Sacchi, M.

AU - Warusavitarne, J.

AU - Hart, A.

AU - Yassin, N.A.

AU - Kennelly, R.P.

AU - Cullen, G.J.

AU - Winter, D.C.

AU - Hawthorne, A.B.

AU - Torkington, J.

AU - Bemelman, W.A.

PY - 2015/1/1

Y1 - 2015/1/1

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. TRIAL REGISTRATION: Nederlands Trial Register identifier: NTR4137 (registered on 23 August 2013).

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. TRIAL REGISTRATION: Nederlands Trial Register identifier: NTR4137 (registered on 23 August 2013).

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

IS - 1

M1 - 366

ER -