{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T12:29:47Z","timestamp":1789388987232,"version":"build-2803163510"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2021,11,13]],"date-time":"2021-11-13T00:00:00Z","timestamp":1636761600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Crohn\u2019s and Colitis Foundation Career Development","award":["607934"],"award-info":[{"award-number":["607934"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,9,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The lack of standardized methods for clinical trial design and disease activity assessment has contributed to an absence of approved medical therapies for the prevention of postoperative Crohn\u2019s disease (CD). We developed recommendations for regulatory trial design for this indication and for endoscopic assessment of postoperative CD activity.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>An international panel of 19 gastroenterologists was assembled. Modified Research and Development\/University of California Los Angeles methodology was used to rate the appropriateness of 196 statements using a 9-point Likert scale in 2 rounds of voting. Results were reviewed and discussed between rounds.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Inclusion of patients with a history of completely resected ileocolonic CD in regulatory clinical trials for the prevention of postoperative recurrence was appropriate. Given the absence of approved medical therapies, a placebo-controlled design with a primary end point of endoscopic remission at 52 weeks was appropriate for drug development for this indication; however, there was uncertainty regarding the appropriateness of a coprimary end point of symptomatic and endoscopic remission and the use of currently available patient-reported outcome measures. The modified Rutgeerts Score, endoscopic assessment of the anastomosis, and a minimum of 5cm of neoterminal ileum were also appropriate; although the appropriateness of other indices including the Simple Endoscopic Score for CD for endoscopic assessment of postoperative CD activity was uncertain.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>A framework for regulatory trial design for the prevention of postoperative CD recurrence and endoscopic assessment of disease activity has been developed. Research to empirically validate end points for these trials is needed.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ibd\/izab259","type":"journal-article","created":{"date-parts":[[2021,11,18]],"date-time":"2021-11-18T02:20:45Z","timestamp":1637202045000},"page":"1321-1331","source":"Crossref","is-referenced-by-count":12,"title":["Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn\u2019s Disease"],"prefix":"10.1093","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3158-8014","authenticated-orcid":false,"given":"Jurij","family":"Hanzel","sequence":"first","affiliation":[{"name":"Department of Gastroenterology , UMC Ljubljana, Ljubljana , Slovenia"},{"name":"Alimentiv Inc. , London, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8603-898X","authenticated-orcid":false,"given":"Vipul","family":"Jairath","sequence":"additional","affiliation":[{"name":"Alimentiv Inc. , London, Ontario , Canada"},{"name":"Division of Gastroenterology, Western University , London, Ontario , Canada"},{"name":"Department of Epidemiology and Biostatistics, Western University , London, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"De Cruz","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, The Austin Hospital , Melbourne , Australia"},{"name":"Department of Medicine, Austin Academic Centre, University of Melbourne , Melbourne , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonardo","family":"Guizzetti","sequence":"additional","affiliation":[{"name":"Alimentiv Inc. , London, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa M","family":"Shackelton","sequence":"additional","affiliation":[{"name":"Alimentiv Inc. , London, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4027-7365","authenticated-orcid":false,"given":"Peter","family":"Bossuyt","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Imelda General Hospital , Bonheiden , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marjolijn","family":"Duijvestein","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM), University of Amsterdam , Amsterdam , the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parambir S","family":"Dulai","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, University of California San Diego , La Jolla, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes","family":"Grossmann","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine I, Bethesda Hospital, Johanniter GmbH , M\u00f6nchengladbach , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert P","family":"Hirten","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine, The Susan & Leonard Feinstein IBD Center Division of Gastroenterology , Mount Sinai, New York City, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8679-2541","authenticated-orcid":false,"given":"Reena","family":"Khanna","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Western University , London, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4971-6902","authenticated-orcid":false,"given":"Julian","family":"Panes","sequence":"additional","affiliation":[{"name":"Hospital Clinic de Barcelona, IDIBAPS, CIBERehd , Barcelona , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine , Vandoeuvre-l\u00e8s-Nancy , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7681-8111","authenticated-orcid":false,"given":"Miguel","family":"Regueiro","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic , Cleveland, Ohio , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David T","family":"Rubin","sequence":"additional","affiliation":[{"name":"University of Chicago Medicine Inflammatory Bowel Disease Center , Chicago, Illinois , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siddharth","family":"Singh","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, University of California San Diego , La Jolla, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan W","family":"Stidham","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Michigan Medical School , Ann Arbor, Michigan , USA"},{"name":"Department of Computational Medicine and Bioinformatics. University of Michigan Medical School , Ann Arbor, Michigan , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William J","family":"Sandborn","sequence":"additional","affiliation":[{"name":"Alimentiv Inc. , London, Ontario , Canada"},{"name":"Division of Gastroenterology, University of California San Diego , La Jolla, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian G","family":"Feagan","sequence":"additional","affiliation":[{"name":"Alimentiv Inc. , London, Ontario , Canada"},{"name":"Division of Gastroenterology, Western University , London, Ontario , Canada"},{"name":"Department of Epidemiology and Biostatistics, Western University , London, Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geert R","family":"D\u2019Haens","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam Gastroenterology Endocrinology 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