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. 2015 Aug 20;16:366. doi: 10.1186/s13063-015-0831-x.

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).

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / economics
  • Anti-Inflammatory Agents / therapeutic use*
  • Combined Modality Therapy
  • Cost-Benefit Analysis
  • Crohn Disease / diagnosis
  • Crohn Disease / economics
  • Crohn Disease / immunology
  • Crohn Disease / therapy*
  • Digestive System Surgical Procedures / adverse effects
  • Digestive System Surgical Procedures / economics
  • Digestive System Surgical Procedures / methods*
  • Drainage / adverse effects
  • Drainage / economics
  • Drainage / methods*
  • Drug Therapy, Combination
  • Europe
  • Gastrointestinal Agents / adverse effects
  • Gastrointestinal Agents / economics
  • Gastrointestinal Agents / therapeutic use*
  • Health Care Costs
  • Humans
  • Magnetic Resonance Imaging
  • Mercaptopurine / therapeutic use
  • Quality of Life
  • Rectal Fistula / diagnosis
  • Rectal Fistula / economics
  • Rectal Fistula / immunology
  • Rectal Fistula / therapy*
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*
  • Tumor Necrosis Factor-alpha / immunology

Substances

  • Anti-Inflammatory Agents
  • Gastrointestinal Agents
  • Tumor Necrosis Factor-alpha
  • Mercaptopurine

Associated data

  • NTR/NTR4137