Outcomes and Endpoints of Postoperative Recurrence in Crohn's Disease: Systematic Review and Consensus Conference

Nassim Hammoudi, David Sachar, Geert D'Haens, Walter Reinisch, Paulo Gustavo Kotze, Severine Vermeire, Jürgen Schölmerich, Michael A. Kamm, Anne Griffiths, Julian Panes, Subrata Ghosh, Corey A. Siegel, Willem Bemelman, Colm O'Morain, Flavio Steinwurz, Phillip Fleshner, Gerassimos J. Mantzaris, Bruce Sands, Maria T. Abreu, Iris DotanDan Turner, Axel Dignass, Matthieu Allez

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Outcomes after ileocolonic resection in Crohn's disease [CD] are heterogeneous, and a clear definition of postoperative recurrence remains to be determined. Our Endpoints Working Group of the International Organization for the study of Inflammatory Bowel Disease [IOIBD] aimed to standardise postoperative outcomes, to discuss which endpoints should be used for postoperative clinical trials, and to define those which could be used in trials or registries. METHODS: Based on a systematic review of the literature, recommendations and statements were drafted and sent to all IOIBD members for a first round of voting. Recommendations and statements were revised based on the voters' comments during a consensus hybrid conference open to all IOIBD members. If no agreement was reached after two rounds of voting, the statement was excluded. RESULTS: In the systematic review, 3071 manuscripts were screened of which 434 were included. Sixteen recommendations were identified, of which 11 were endorsed. Recommendations and statements include that endoscopy remains the gold standard and should be used as a short-term primary endpoint in both observational cohorts and randomised controlled trials. Clinical symptoms classically used in clinical trials for luminal CD are not reliable in this specific situation. For that reason, longer-term endpoints should be based on the evidence of macroscopic inflammation assessed by imaging techniques, endoscopy, or as reflected by the presence of complications. CONCLUSIONS: Agencies recommend the use of clinical evaluations, as in the case of luminal CD, and do not recognise primary endpoints based solely on endoscopy. This consensus has led to agreement on the need to define postoperative endoscopy-based and/or imaging-based endpoints.

Original languageEnglish
Pages (from-to)943-957
Number of pages15
JournalJournal of Crohn's and Colitis
Volume18
Issue number6
DOIs
StatePublished - 3 Jun 2024

Bibliographical note

Publisher Copyright:
© The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please

Keywords

  • biotherapy
  • clinical trials
  • IBD
  • surgery
  • treatment

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