{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,17]],"date-time":"2025-09-17T00:18:37Z","timestamp":1758068317203,"version":"3.44.0"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,9,16]],"date-time":"2025-09-16T00:00:00Z","timestamp":1757980800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,9,16]],"date-time":"2025-09-16T00:00:00Z","timestamp":1757980800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100018935","name":"Universit\u00e4tsklinikum Erlangen","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100018935","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract\n<\/jats:title>\n          <jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>Morbidity due to anastomotic leakage is a major concern in transthoracic oesophagectomy. The aim of this randomised trial is to evaluate whether a circumferential suture reinforcement of the stapled end-to-side anastomosis in robot-assisted minimally invasive Ivor-Lewis oesophagectomy (RAMIE) leads to a reduced incidence of anastomotic leakages in the postoperative course.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods\/design<\/jats:title>\n            <jats:p>This is a multi-centre randomised, double-blind, superiority trial with an adaptive sample size design undergoing RAMIE for malignant tumours. Patients will be randomised 1:1 into two study arms. In study arm A, participants will receive a standard circular-stapled end-to-side oesophagogastric anastomosis, while in study arm B, the anastomosis will have a circumferential suture reinforcement. The primary endpoint is the rate of anastomotic leakage. Secondary endpoints are incision-to-suture time, duration of circumferential suture reinforcement, anastomotic stenosis rate, postoperative morbidity and mortality, and quality of life.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Discussion<\/jats:title>\n            <jats:p>This randomised controlled trial will assess the impact of circumferential suture reinforcement of the oesophagogastric anastomosis on short-term outcomes and quality of life of patients undergoing robot-assisted minimally invasive Ivor-Lewis oesophagectomy.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Trial regsitration<\/jats:title>\n            <jats:p>DRKS00034787. Registered on 7 October 2024.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1186\/s13063-025-08995-4","type":"journal-article","created":{"date-parts":[[2025,9,16]],"date-time":"2025-09-16T06:20:21Z","timestamp":1758003621000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparison of standard circular stapler anastomosis with or without circumferential suture enhancement in patients with robot-assisted Ivor-Lewis oesophagectomy due to malignant tumours of the oesophagus and oesophagogastric junction\u2014a multi-centre, randomised, superiority study (STITCHES)"],"prefix":"10.1186","volume":"26","author":[{"given":"Janik","family":"Hinkelmann","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helena","family":"Reitberger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-1989-5064","authenticated-orcid":false,"given":"Bruno Bancke","family":"Laverde","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1257-5517","authenticated-orcid":false,"given":"Andreas R. 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The local Ethical Committee at the Friedrich-Alexander-University Erlangen-Nuremberg approved the study protocol (decision number 24\u2013205-B). Every patient has to be informed about the trial and declare his or her consent to participate in the study. This trial was registered in advance at the German Clinical Trials Register (DRKS00034787, ).","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"The results will be published in a peer-reviewed journal. Furthermore, the results will be presented at appropriate national and international conferences. The datasets analysed during the current study and the statistical code will be made available from the corresponding author upon reasonable request, as will the full protocol. Furthermore, any data required to support the protocol can be supplied on request.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"341"}}