{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T15:57:01Z","timestamp":1790524621719,"version":"4.1.0"},"reference-count":21,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:00:00Z","timestamp":1789948800000},"content-version":"unspecified","delay-in-days":20,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005565","name":"Johnson & Johnson Innovative Medicine","doi-asserted-by":"publisher","award":["IIS MIP-2024-10"],"award-info":[{"award-number":["IIS MIP-2024-10"]}],"id":[{"id":"10.13039\/100005565","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,8,27]]},"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT07376980\">NCT07376980<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-120621","type":"journal-article","created":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T15:32:34Z","timestamp":1790523154000},"page":"e120621","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Modified single-stapled anastomosis in laparoscopic or robotic low anterior resection for rectal cancer: protocol for a multicentre randomised controlled trial"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct07376980","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2606-9973","authenticated-orcid":false,"given":"Hyo Seon","family":"Ryu","sequence":"first","affiliation":[{"name":"Division of Colon and Rectal Surgery, Department of Surgery, Korea University College of Medicine, Seoul, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jung-Myun","family":"Kwak","sequence":"additional","affiliation":[{"name":"Division of Colon and Rectal Surgery, Department of Surgery, Korea University College of Medicine, Seoul, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Se-Jin","family":"Baek","sequence":"additional","affiliation":[{"name":"Division of Colon and Rectal Surgery, Department of Surgery, Korea University College of Medicine, Seoul, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Byung Soh","family":"Min","sequence":"additional","affiliation":[{"name":"Department of Surgery, Yonsei University College of Medicine, Seoul, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min Soo","family":"Cho","sequence":"additional","affiliation":[{"name":"Department of Surgery, Yonsei University College of Medicine, Seoul, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seung Yoon","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Surgery, Yonsei University College of Medicine, Seoul, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sun Jin","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Surgery, Kyung Hee University Hospital, Seoul, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eun Ji","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Surgery, Kyung Hee University Hospital, Seoul, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun Seok","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Surgery, Kyungpook National University Chilgok Hospital, Daegu, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seung Ho","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Surgery, Kyungpook National University Chilgok Hospital, Daegu, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Su Jin","family":"Kang","sequence":"additional","affiliation":[{"name":"Department of Surgery, Kyungpook National University Chilgok Hospital, Daegu, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bong-Hyeon","family":"Kye","sequence":"additional","affiliation":[{"name":"General Surgery, The Catholic University of Korea St. Vincent\u2019s Hospital, Suwon, Gyeonggi-do, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"Yoo","sequence":"additional","affiliation":[{"name":"General Surgery, The Catholic University of Korea St. Vincent\u2019s Hospital, Suwon, Gyeonggi-do, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ji Yeon","family":"Mun","sequence":"additional","affiliation":[{"name":"General Surgery, The Catholic University of Korea St. Vincent\u2019s Hospital, Suwon, Gyeonggi-do, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0046-8175","authenticated-orcid":false,"given":"Ji Won","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Surgery, Seoul National University College of Medicine, Jongno-gu, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min Jung","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Surgery, Seoul National University College of Medicine, Jongno-gu, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Young Jin","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Surgery, Seoul National University College of Medicine, Jongno-gu, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin","family":"Kim","sequence":"additional","affiliation":[{"name":"Division of Colon and Rectal Surgery, Department of Surgery, Korea University College of Medicine, Seoul, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,9,21]]},"reference":[{"key":"2026092107250644000_16.9.e120621.1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1414882"},{"key":"2026092107250644000_16.9.e120621.2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(14)70205-0"},{"key":"2026092107250644000_16.9.e120621.3","doi-asserted-by":"crossref","first-page":"7906","DOI":"10.3748\/wjg.v23.i44.7906","article-title":"Short-term clinical outcomes of laparoscopic vs open rectal excision for rectal cancer: A systematic review and meta-analysis","volume":"23","author":"Mart\u00ednez-P\u00e9rez","year":"2017","journal-title":"World J Gastroenterol"},{"key":"2026092107250644000_16.9.e120621.4","doi-asserted-by":"crossref","DOI":"10.1097\/MD.0000000000013704","article-title":"Short- and long-term outcomes of laparoscopic versus open surgery for rectal cancer: A systematic review and meta-analysis of randomized controlled trials","volume":"97","author":"Lin","year":"2018","journal-title":"Medicine (Baltimore)"},{"key":"2026092107250644000_16.9.e120621.5","doi-asserted-by":"publisher","DOI":"10.1007\/s00384-016-2744-x"},{"key":"2026092107250644000_16.9.e120621.6","doi-asserted-by":"crossref","first-page":"1533","DOI":"10.1007\/s00384-015-2359-7","article-title":"The types of anastomotic leakage that develop following anterior resection for rectal cancer demonstrate distinct characteristics and oncologic outcomes","volume":"30","author":"Lim","year":"2015","journal-title":"Int J Colorectal Dis"},{"key":"2026092107250644000_16.9.e120621.7","doi-asserted-by":"crossref","first-page":"1283","DOI":"10.1002\/jso.25921","article-title":"The influence of anastomotic leakage for rectal cancer oncologic outcome: A systematic review and meta-analysis","volume":"121","author":"Yang","year":"2020","journal-title":"J Surg Oncol"},{"key":"2026092107250644000_16.9.e120621.8","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.6662"},{"key":"2026092107250644000_16.9.e120621.9","doi-asserted-by":"crossref","first-page":"381","DOI":"10.1089\/lap.2010.0059","article-title":"Effectiveness and safety of laparoscopic resection versus open surgery in patients with rectal cancer: a randomized, controlled trial from China","volume":"21","author":"Liang","year":"2011","journal-title":"J Laparoendosc Adv Surg Tech A"},{"key":"2026092107250644000_16.9.e120621.10","doi-asserted-by":"publisher","DOI":"10.1007\/s10350-006-0798-5"},{"key":"2026092107250644000_16.9.e120621.11","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(13)70016-0"},{"key":"2026092107250644000_16.9.e120621.12","doi-asserted-by":"crossref","first-page":"e1218","DOI":"10.1097\/SLA.0000000000003805","article-title":"Robotic Surgery for Rectal Cancer Provides Advantageous Outcomes Over Laparoscopic Approach: Results From a Large Retrospective Cohort","volume":"274","author":"Crippa","year":"2021","journal-title":"Ann Surg"},{"key":"2026092107250644000_16.9.e120621.13","doi-asserted-by":"crossref","first-page":"812","DOI":"10.1097\/DCR.0000000000001978","article-title":"Robot Surgery Shows Similar Long-term Oncologic Outcomes as Laparoscopic Surgery for Mid\/Lower Rectal Cancer but Is Beneficial to ypT3\/4 After Preoperative Chemoradiation","volume":"64","author":"Park","year":"2021","journal-title":"Dis Colon Rectum"},{"key":"2026092107250644000_16.9.e120621.14","doi-asserted-by":"crossref","first-page":"126","DOI":"10.1016\/j.jss.2014.07.009","article-title":"Endoscopic evaluation of clinical colorectal anastomotic leakage","volume":"193","author":"Ikeda","year":"2015","journal-title":"J Surg Res"},{"key":"2026092107250644000_16.9.e120621.15","doi-asserted-by":"crossref","first-page":"771","DOI":"10.1007\/s11605-012-2122-0","article-title":"Feasibility and impact on surgical outcomes of modified double-stapling technique for patients undergoing laparoscopic anterior resection","volume":"17","author":"Kang","year":"2013","journal-title":"J Gastrointest Surg"},{"key":"2026092107250644000_16.9.e120621.16","doi-asserted-by":"crossref","DOI":"10.3389\/fsurg.2022.1003854","article-title":"Double-stapled anastomosis without \u201cdog-ears\u201d reduces the anastomotic leakage in laparoscopic anterior resection of rectal cancer: A prospective, randomized, controlled study","volume":"9","author":"Yang","year":"2022","journal-title":"Front Surg"},{"key":"2026092107250644000_16.9.e120621.17","doi-asserted-by":"publisher","DOI":"10.1016\/j.surg.2009.10.012"},{"key":"2026092107250644000_16.9.e120621.18","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0b013e3180603024"},{"key":"2026092107250644000_16.9.e120621.19","doi-asserted-by":"crossref","first-page":"1129","DOI":"10.1016\/j.surg.2015.11.006","article-title":"Diverting ileostomy versus no diversion after low anterior resection for rectal cancer: A prospective, randomized, multicenter trial","volume":"159","author":"Mrak","year":"2016","journal-title":"Surgery"},{"key":"2026092107250644000_16.9.e120621.20","doi-asserted-by":"publisher","DOI":"10.1007\/s11605-009-1067-4"},{"key":"2026092107250644000_16.9.e120621.21","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1001\/2013.jamasurg.2","article-title":"Risk factors for anastomotic leakage after anterior resection for rectal cancer","volume":"148","author":"Kang","year":"2013","journal-title":"JAMA Surg"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2026-120621","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T15:32:37Z","timestamp":1790523157000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2026-120621"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":21,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2026,9,21]]},"published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1136\/bmjopen-2026-120621"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2026-120621","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9]]}}}