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

Aim: During the last decade, treatment protocols have changed for patients with ileocolic Crohn's disease. Anti‐tumour necrosis factor (anti‐TNF) has become part of standard medical treatment, usually in a step‐up approach. The aim was to analyse if improved medical treatment has resulted in more limited ileocolic resections and a longer interval between diagnosis and surgery.Method: Patients undergoing ileocolic resection for Crohn's disease were included (1999–2014). Patient characteristics were compared to the results of a population‐based study (between 2004 and 2010) previously performed in the catchment area of the present tertiary referral centre. Time trends were analysed using the Cochrane–Armitage trend, Spearman's correlation coefficient and linear regression.Results: In total, 195 patients undergoing ileocolic resection were included. Patient characteristics were not significantly different from the background cohort, confirming a representative study group. Sixty‐three patients were men (32.3%, median age at surgery 30.0 years, interquartile range 23.0–40.0). Anti‐TNF and immunomodulator use prior to surgery increased significantly during the study period (χ² = 49.1, P < 0.001). Over the years, a significant increase in time from diagnosis to operation was found (median 39.0 months, interquartile range 12.0–86.0, rho 0.175, P = 0.014). The length of the resected ileum did not change significantly (median 20.0 cm, interquartile range 12.0–30.0, rho −0.107, P = 0.143). The number of fistulas or postoperative complications that needed re‐intervention was not significantly different between the groups with or without anti‐TNF.Conclusion: This study demonstrated that over time patients with ileocolic Crohn's disease who eventually underwent ileocolic resection have been treated more intensively medically; however, this did not result in reduced specimen size.