{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T08:25:00Z","timestamp":1793262300052,"version":"4.5.0"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2020,1,10]],"date-time":"2020-01-10T00:00:00Z","timestamp":1578614400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001826","name":"Netherlands Organization for Health Research and Development","doi-asserted-by":"crossref","award":["837002002"],"award-info":[{"award-number":["837002002"]}],"id":[{"id":"10.13039\/501100001826","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100011684","name":"Crohn's and Colitis Foundation","doi-asserted-by":"publisher","award":["210270"],"award-info":[{"award-number":["210270"]}],"id":[{"id":"10.13039\/100011684","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,9,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background and Aims<\/jats:title>\n                  <jats:p>Most patients with perianal Crohn\u2019s 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\u2019s disease fistulas would result in less re-interventions, compared with anti-TNF and compared with surgical closure.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This randomised trial was performed in 19 European centres. Patients with high perianal Crohn\u2019s 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Between 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\u2005=\u20050.02]. 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The results imply that chronic seton treatment should not be recommended as the sole treatment for perianal Crohn\u2019s fistulas.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjaa004","type":"journal-article","created":{"date-parts":[[2020,1,9]],"date-time":"2020-01-09T20:09:46Z","timestamp":1578600586000},"page":"1049-1056","source":"Crossref","is-referenced-by-count":115,"title":["Treatment of Perianal Fistulas in Crohn\u2019s Disease, Seton Versus Anti-TNF Versus Surgical Closure Following Anti-TNF [PISA]: A Randomised Controlled Trial"],"prefix":"10.1093","volume":"14","author":[{"given":"Karin A","family":"Wasmann","sequence":"first","affiliation":[{"name":"Department of Surgery, Amsterdam UMC, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E Joline","family":"de Groof","sequence":"additional","affiliation":[{"name":"Department of Surgery, Amsterdam UMC, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8447-6254","authenticated-orcid":false,"given":"Merel E","family":"Stellingwerf","sequence":"additional","affiliation":[{"name":"Department of Surgery, Amsterdam UMC, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geert R","family":"D\u2019Haens","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cyriel Y","family":"Ponsioen","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krisztina B","family":"Gecse","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcel G W","family":"Dijkgraaf","sequence":"additional","affiliation":[{"name":"Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael F","family":"Gerhards","sequence":"additional","affiliation":[{"name":"Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeroen M","family":"Jansen","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Apollo","family":"Pronk","sequence":"additional","affiliation":[{"name":"Department of Surgery, Diakonessenhuis, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastiaan A C","family":"van Tuyl","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Diakonessenhuis, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David D E","family":"Zimmerman","sequence":"additional","affiliation":[{"name":"Department of Surgery, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karlien F","family":"Bruin","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonino","family":"Spinelli","sequence":"additional","affiliation":[{"name":"Department of Surgery, Humanitas Research Hospital and Humanitas University, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Center- IRCCS-, Rozzano, Milan, Italy"},{"name":"Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jarmila D W","family":"van der Bilt","sequence":"additional","affiliation":[{"name":"Department of Surgery, Flevoziekenhuis, Almere, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco W","family":"Mundt","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, 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