Modified single-stapled anastomosis in laparoscopic or robotic low anterior resection for rectal cancer: protocol for a multicentre randomised controlled trial.
Rattachement africain : kr, jp. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
INTRODUCTION: Anastomotic leakage remains one of the most serious complications after low anterior resection for rectal cancer. The modified single-stapled technique (MST) eliminates the intersection between linear and circular staple lines and may reduce leakage compared with the conventional double-stapled technique (DST). This trial aims to determine whether MST reduces anastomotic leakage in patients undergoing laparoscopic or robotic low anterior resection. METHODS AND ANALYSIS: This is a multicentre, parallel-group and superiority randomised controlled trial conducted in six tertiary hospitals in South Korea. A total of 450 patients undergoing laparoscopic or robotic low anterior resection for rectal cancer will be randomised in a 1:1 ratio to MST or DST. Randomisation will be stratified by sex and neoadjuvant treatment. The primary outcome is anastomotic leakage within 30 days after surgery, confirmed by clinical findings and routine postoperative abdominopelvic CT. Secondary outcomes include additional distal resection margin length, local recurrence, 3-year disease-free survival and overall survival. Analyses will follow the intention-to-treat principle. ETHICS AND DISSEMINATION: The study was approved by the Institutional Review Board of Korea University Anam Hospital (2025AN0114). Results will be disseminated through peer-reviewed journals and scientific meetings. TRIAL REGISTRATION NUMBER: NCT07376980.
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Korea University Department of Surgery pays non établi dans la noticeUniversité ou école supérieure
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Yonsei University Department of Surgery pays non établi dans la noticeUniversité ou école supérieure
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Kyung Hee University Dental Hospital pays non établi dans la noticeÉtablissement de santé
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Kyungpook National University Hospital pays non établi dans la noticeÉtablissement de santé
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Kyungpook National University Chilgok Hospital Department of Surgery pays non établi dans la noticeÉtablissement de santé
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The Catholic University of Korea St. Vincent's Hospital General Surgery pays non établi dans la noticeÉtablissement de santé
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Seoul National University Department of Surgery pays non établi dans la noticeUniversité ou école supérieure
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Kyung Hee University Hospital Department of Surgery pays non établi dans la noticeUniversité ou école supérieure
Department of Surgery — Korea University, Department of Surgery — Yonsei University et Kyung Hee University Dental Hospital, avec 5 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.