Evidence map›Paper›PMID 31919501›Full record

Trial reportJournal of Crohn's & colitis2020

Treatment of Perianal Fistulas in Crohn's Disease, Seton Versus Anti-TNF Versus Surgical Closure Following Anti-TNF [PISA]: A Randomised Controlled Trial.

Karin A Wasmann, E Joline de Groof, Merel E Stellingwerf, Geert R D'Haens, Cyriel Y Ponsioen, Krisztina B Gecse, Marcel G W Dijkgraaf, Michael F Gerhards, Jeroen M Jansen, Apollo Pronk and 9 more

Erratum issuedOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Crohn's & colitis, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 59 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 8 pooled it
10.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 8 syntheses or guidelines pooled it, 111 citations in OpenAlex.

  1. Perianal fistulizing Crohn's disease: Clinical practice update from Colitis and Crohn's Foundation (India).Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026
    Guideline
  2. A systematic review of the methodological quality of randomised trials in IBD surgery.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 6 institutions in 2 countries.

Karin A WasmannDepartment of Surgery, Amsterdam UMC, Amsterdam, The Netherlands.
E Joline de GroofDepartment of Surgery, Amsterdam UMC, Amsterdam, The Netherlands.
Merel E StellingwerfDepartment of Surgery, Amsterdam UMC, Amsterdam, The Netherlands.
Geert R D'HaensDepartment of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands.
Cyriel Y PonsioenDepartment of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands.
Krisztina B GecseDepartment of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands.
Marcel G W DijkgraafDepartment of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, Amsterdam, The Netherlands.
Michael F GerhardsDepartment of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
Jeroen M JansenDepartment of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
Apollo PronkDepartment of Surgery, Diakonessenhuis, Utrecht, The Netherlands.
Sebastiaan A C van TuylDepartment of Gastroenterology and Hepatology, Diakonessenhuis, Utrecht, The Netherlands.
David D E ZimmermanDepartment of Surgery, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.
Karlien F BruinDepartment of Gastroenterology and Hepatology, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.
Antonino SpinelliDepartment of Surgery, Humanitas Research Hospital and Humanitas University, Milan, Italy.
Silvio DaneseDepartment of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan, Italy.
Jarmila D W van der BiltDepartment of Surgery, Flevoziekenhuis, Almere, The Netherlands.
Marco W MundtDepartment of Gastroenterology and Hepatology, Flevoziekenhuis, Almere, The Netherlands.
Willem A BemelmanDepartment of Surgery, Amsterdam UMC, Amsterdam, The Netherlands.
Christianne J BuskensDepartment of Surgery, Amsterdam UMC, Amsterdam, The Netherlands.
Amsterdam University Medical Centers · NLDiakonessenhuis hospital · NLElisabeth-TweeSteden Ziekenhuis · NLFlevoziekenhuis · NLHumanitas University · ITOLVG · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsMost patients with perianal Crohn's fistula receive medical treatment with anti-tumour necrosis factor [TNF], but the results of anti-TNF treatment have not been directly compared with chronic seton drainage or surgical closure. The aim of this study was to assess if chronic seton drainage for patients with perianal Crohn's disease fistulas would result in less re-interventions, compared with anti-TNF and compared with surgical closure.

methodsThis randomised trial was performed in 19 European centres. Patients with high perianal Crohn's fistulas with a single internal opening were randomly assigned to: i] chronic seton drainage for 1 year; ii] anti-TNF therapy for 1 year; and iii] surgical closure after 2 months under a short course anti-TNF. The primary outcome was the cumulative number of patients with fistula-related re-intervention[s] at 1.5 years. Patients declining randomisation due to a specific treatment preference were included in a parallel prospective PISA registry cohort.

resultsBetween September 14, 2013 and November 20, 2017, 44 of the 126 planned patients were randomised. The study was stopped by the data safety monitoring board because of futility. Seton treatment was associated with the highest re-intervention rate [10/15, versus 6/15 anti-TNF and 3/14 surgical closure patients, p = 0.02]. No substantial differences in perianal disease activity and quality of life between the three treatment groups were observed. Interestingly, in the PISA prospective registry, inferiority of chronic seton treatment was not observed for any outcome measure.

conclusionsThe results imply that chronic seton treatment should not be recommended as the sole treatment for perianal Crohn's fistulas.

Indexed as

AdalimumabDrainageInfliximabQuality of LifeRectal FistulaWound Closure TechniquesAdultCombined Modality TherapyCrohn DiseaseEarly Termination of Clinical TrialsFemaleHumansMaleMedical FutilityOutcome and Process Assessment, Health CarePatient AcuityAdalimumabInfliximabTumor Necrosis Factor Inhibitorsanti-TNFCrohn’s diseaseperianal fistula

Identifiers

PMID31919501
PMCPMC7476637
OpenAlexW2913123771

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.