{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T05:48:26Z","timestamp":1782452906635,"version":"3.54.5"},"reference-count":46,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T00:00:00Z","timestamp":1781740800000},"content-version":"vor","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Colorectal Disease"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>This systematic review aimed to evaluate the design, statistical robustness and real\u2010world applicability of randomised controlled trials in IBD surgery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A systematic review of RCTs involving adult patients with IBD undergoing surgical interventions was conducted. Databases and registries were searched from 2005 to 2025. Dual screening and extraction were performed. Trials were appraised using RoB\u20102, PRECIS\u20102 and fragility index. The study was registered with PROSPERO (CRD420251058758).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>From 5803 abstracts, 18 published RCTs and 26 registered but unpublished trials were identified. Published RCTs had a median planned sample size of 102 participants (IQR 80\u2013143) and recruited a median of 89 (IQR 55\u2013114), with frequent under\u2010recruitment (7\/18, 39%) and early termination (5\/18, 28%). Methodological appraisal revealed that most studies (12\/18, 67%) had some concern for bias on RoB\u20102 assessment. PRECIS\u20102 evaluation showed a tendency towards pragmatic designs. The median fragility index was 3 (IQR 1\u20136). Of registered, unpublished trials, median planned sample size was 155 (IQR 93\u2013196), with the largest study having a planned enrolment of 550 participants.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Surgical RCTs in IBD face challenges across design and delivery, such as modest sample sizes, under\u2010recruitment and statistical fragility. The findings from this review highlight the importance of larger, multicentre and collaborative trials to strengthen the evidence base in IBD surgery.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/codi.70531","type":"journal-article","created":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T04:52:14Z","timestamp":1781844734000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A systematic review of the methodological quality of randomised trials in\n                    <scp>IBD<\/scp>\n                    surgery"],"prefix":"10.1111","volume":"28","author":[{"given":"Kelsey","family":"Aimar","sequence":"first","affiliation":[{"name":"Belfast Health and Social Care Trust  Belfast UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0347-4733","authenticated-orcid":false,"given":"Aditya","family":"Gaur","sequence":"additional","affiliation":[{"name":"Somerset NHS Foundation Trust  Taunton UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Peirson","sequence":"additional","affiliation":[{"name":"Bradford Teaching Hospitals NHS Foundation Trust  Bradford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0450-273X","authenticated-orcid":false,"given":"Josephine","family":"Walshaw","sequence":"additional","affiliation":[{"name":"Leeds Institute of Medical Research University of Leeds  Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas D.","family":"Pinkney","sequence":"additional","affiliation":[{"name":"University Hospitals Birmingham NHS Foundation Trust  Birmingham UK"},{"name":"Department of Applied Health Sciences, College of Medicine &amp; Health University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew J.","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Applied Health Sciences, College of Medicine &amp; Health University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,6,18]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2020.10.039"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.07.041"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjy040"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2012.127"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjae089"},{"key":"e_1_2_12_7_1","unstructured":"Search \u2010 NIHR funding and awards [Internet]. 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