{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T19:31:52Z","timestamp":1793734312283,"version":"4.6.1"},"reference-count":35,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,2,26]],"date-time":"2024-02-26T00:00:00Z","timestamp":1708905600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,2,26]],"date-time":"2024-02-26T00:00:00Z","timestamp":1708905600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Surg"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The most common intestinal operation in Crohn\u2019s disease (CD) is an ileocolic resection. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection for example, handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. The objective of the present study is to compare the three types of anastomoses with respect to endoscopic recurrence at 6\u2009months, gastrointestinal function, and health care consumption.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This is a randomized controlled multicentre superiority trial, allocating patients either to side-to-side stapled anastomosis as advised in current guidelines or a handsewn anastomoses (an end-to-end or Kono-S). It is hypothesized that handsewn anastomoses do better than stapled, and end-to-end perform better than the saccular Kono-S. Two international studies with a similar setup will be conducted mainly in the Netherlands (End2End) and Italy (HAND2END). Patients diagnosed with CD, aged over 16\u2009years in the Netherlands and 18\u2009years in Italy requiring (re)resection of the (neo)terminal ileum are eligible. The first part of the study compares the two handsewn anastomoses with the stapled anastomosis. To detect a clinically relevant difference of 25% in endoscopic recurrence, a total of 165 patients will be needed in the Netherlands and 189 patients in Italy. Primary outcome is postoperative endoscopic recurrence (defined as Rutgeerts score\u00a0\u2265\u00a0i2b) at 6\u2009months. Secondary outcomes are postoperative morbidity, gastrointestinal function, quality of life (QoL) and costs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The research question addresses a knowledge gap within the general practice elucidating which type of anastomosis is superior in terms of endoscopic and clinical recurrence, functionality, QoL and health care consumption. The results of the proposed study might change current practice in contrast to what is advised by the guidelines.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      NCT05246917 for HAND2END and NCT05578235 for End2End (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\/\">http:\/\/www.clinicaltrials.gov\/<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12893-024-02340-3","type":"journal-article","created":{"date-parts":[[2024,2,26]],"date-time":"2024-02-26T00:02:22Z","timestamp":1708905742000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Optimising surgical anastomosis in ileocolic resection for Crohn\u2019s disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES)"],"prefix":"10.1186","volume":"24","author":[{"given":"Anouck E. 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Ann Surg. 2020;272(2):210\u20137.","journal-title":"Ann Surg"}],"container-title":["BMC Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12893-024-02340-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12893-024-02340-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12893-024-02340-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,2,29]],"date-time":"2024-02-29T17:08:50Z","timestamp":1709226530000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcsurg.biomedcentral.com\/articles\/10.1186\/s12893-024-02340-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,26]]},"references-count":35,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["2340"],"URL":"https:\/\/doi.org\/10.1186\/s12893-024-02340-3","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-3514278\/v1","asserted-by":"object"}]},"ISSN":["1471-2482"],"issn-type":[{"value":"1471-2482","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,26]]},"assertion":[{"value":"30 October 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 February 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 February 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This trial will be conducted according to good clinical practice guidelines and the principles of the Declaration of Helsinki. This study has been registered on NCT Govtrial registry under the identification numbers:\n                      \n                      and\n                      \n                      . The HAND2END has been evaluated and approved by the IRCCS San Raffaele Ethical Committee (EC-13\/06\/2022, version 2.0) in June 2022 and. The End2End study has been approved by the Medical Ethical Committee of the Amsterdam UMC, Amsterdam (Latest amendment MEC 2022.0533 version 3.0) in September 2022. The protocol is registered by the Dutch Central Committee on Research Involving Human Subjects (NL81981.018.22). The participating centres will submit to their local EC for approval. At the time of submission of this study protocol, the following hospitals received approval for participation and are therefore open for inclusion: Flevo Hospital (Almere, The Netherlands), IRCCS Humanitas Research Hospital (Milan, Italy), Vanvitelli Hospital of Naples (Naples, Italy). Written informed consent will be obtained from all participants after an explanatory interview.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Written informed consent for publication of their clinical images was obtained from the patient. A copy of the consent form is available for review by the Editor of this journal.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"71"}}