Treatment of perianal fistulas in Crohn’s disease, seton versus anti-TNF versus surgical closure following anti-TNF (PISA): a randomised controlled trial

Trial Overview

Acronym	PISA
Number	NTR4137
Protocol Link	https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0831-x
Public Trial Registry Link	https://www.trialregister.nl/trial/3957
Status	Closed
Category	IBD
Treatment Course	Surgery

Trial Description

In this multicentre, randomised, prospective trial, chronic seton drainage was compared to anti-TNF therapy and isurgical closure following anti-TNF induction for the treatment of high perianal Crohn’s fistulas with a single internal opening based on MRI. The primary outcome was the number of patients with fistula-related re-intervention(s), defined as surgical and/or (re)start of anti-TNF therapy within 1.5 year. Secondary outcomes were the perianal disease activity index (PDAI) and quality of

Chief Investigator

Willem A. Bemelman
prof. dr.

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Lead Centre

Amsterdam UMC
Meibergdreef 9
Amsterdam
1105 AZ
the Netherlands

Website

Additional Information

Full Research Summary

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Objective:	Most patients with draining perianal Crohn’s disease fistulas receive medical treatment with anti-TNF. So far, outcomes of this medical approach have not been directly compared to chronic seton drainage or surgical closure. We hypothesized that chronic seton drainage would result in fewer re-interventions compared to anti-TNF medication with or without subsequent surgical closure.
Aim:	: Most patients with draining perianal Crohn’s disease fistulas receive medical treatment with anti-TNF. So far, outcomes of this medical approach have not been directly compared to chronic seton drainage or surgical closure. We hypothesized that chronic seton drainage would result in fewer re-interventions compared to anti-TNF medication with or without subsequent surgical closure.
Methods:	In this multicentre, randomised, prospective trial, chronic seton drainage was compared to i) long-term anti-TNF therapy and ii) surgical closure following anti-TNF induction for the treatment of high perianal Crohn’s fistulas with a single internal opening based on MRI. Patients with proctitis, rectovaginal fistulas, and patients who previously failed anti-TNF treatment were excluded. Patients were analysed according to the intention-to-treat principle. The primary outcome was the number of patients with fistula-related re-intervention(s), defined as surgical and/or (re)start of anti-TNF therapy within 1.5 year. Secondary outcomes were the perianal disease activity index (PDAI) and quality of life (QoL). Patients refusing randomisation due to a specific treatment preference were included in a parallel prospective PISA registry cohort.
Reason for International Trial:	Assessing a broad catching and implementation area

Trial Details

Treatment of perianal fistulas in Crohn’s disease, seton versus anti-TNF versus surgical closure following anti-TNF (PISA): a randomised controlled trial

Trial Overview

Trial Description

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Trial Details

Treatment of perianal fistulas in Crohn’s disease, seton versus anti-TNF versus surgical closure following anti-TNF (PISA): a randomised controlled trial

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Additional Information

Research

Why join us?

Members

Research

Education

News & Events

About ESCP

Contact Us

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