{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T03:20:25Z","timestamp":1785468025262,"version":"3.56.0"},"reference-count":8,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,2,13]],"date-time":"2023-02-13T00:00:00Z","timestamp":1676246400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Surg."],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Low anterior resection for rectal cancer is commonly associated with a diverting stoma. In general, the stoma is closed 3 months after the initial operation. The diverting stoma reduces the rate of anastomotic leakage as well as the severeness of a potential leakage itself. Nevertheless, anastomotic leakage is still a life-threatening complication and might reduce the quality of life in the short and long term. In case of leakage, the construction can be converted into a Hartmann situation or it could be treated by endoscopic vacuum therapy or by leaving the drains. In recent years, endoscopic vacuum therapy has become the treatment of choice in many institutions. In this study, the hypothesis is to be evaluated, if a prophylactic endoscopic vacuum therapy reduces the rate of anastomotic leakage after rectal resections.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A multicenter parallel group randomized controlled trial is planned in as many as possible centers in Europe. The study aims to recruit 362 analyzable patients with a resection of the rectum combined with a diverting ileostoma. The anastomosis has to be between 2 and 8\u2005cm off the anal verge. Half of these patients receive a sponge for 5 days, and the control group is treated as usual in the participating hospitals. There will be a check for anastomotic leakage after 30 days. Primary end point is the rate of anastomotic leakages. The study will have 60% power to detect a difference of 10%, at a one-sided alpha significance level of 5%, assuming an anastomosis leakage rate of 10%\u201315%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>If the hypothesis proves to be true, anastomosis leakage could be reduced significantly by placing a vacuum sponge over the anastomosis for 5 days.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>The trial is registered at DRKS: DRKS00023436. It has been accredited by Onkocert of the German Society of Cancer: ST-D483. The leading Ethics Committee is the Ethics Committee of Rostock University with the registration ID A 2019\u20130203.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fsurg.2022.1099549","type":"journal-article","created":{"date-parts":[[2023,2,13]],"date-time":"2023-02-13T05:25:50Z","timestamp":1676265950000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":5,"title":["SEVTAR\u2014A multicenter randomized controlled trial to investigate the impact of prophylactic endoluminal placed vacuum sponge for prevention of anastomotic leakage after low rectal resections"],"prefix":"10.3389","volume":"9","author":[{"given":"Leif","family":"Schiffmann","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Becker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leendert","family":"Develing","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Varga-Szabo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Scheidereiter-Kr\u00fcger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hubert","family":"Zirngibl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Seifert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lothar","family":"Biermann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Schl\u00fcter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felicitas","family":"Tumczak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arved","family":"Weimann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boris","family":"Jansen-Winkeln","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingo","family":"Wallstabe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Schwandner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Denecke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clemens","family":"Schafmayer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Imad","family":"Kamaleddine","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Albrecht","family":"Stier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katharina","family":"Haegele","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Kindler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Michling","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ernst-Wilhelm","family":"Horling","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrike","family":"Denzer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2023,2,13]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"677","DOI":"10.1016\/j.ijrobp.2009.11.007","article-title":"A phase II trial of neoadjuvant preoperative chemoradiotherapy with S1 plus irinotecan and radiation in patients with locally advanced rectal cancer: clinical feasibility and response rate","volume":"79","author":"Sato","year":"2011","journal-title":"Int J Radiat Oncol Biol Phys"},{"key":"B2","doi-asserted-by":"publisher","first-page":"257","DOI":"10.1007\/s00384-007-0408-6","article-title":"Tumor response to neoadjuvant chemoradiation in rectal cancer: predictor for surgical morbidity?","volume":"23","author":"Horisberger","year":"2008","journal-title":"Int J Colorectal Dis"},{"key":"B3","doi-asserted-by":"publisher","first-page":"412","DOI":"10.1007\/DCR.0b013e318197e1b1","article-title":"Diverting stoma after low anterior resection: more arguments in favor","volume":"52","author":"Ulrich","year":"2009","journal-title":"Dis Colon Rectum"},{"key":"B4","doi-asserted-by":"publisher","first-page":"964","DOI":"10.1007\/s00104-010-1928-0","article-title":"Protective stoma after deep anterior rectal resection: pro","volume":"81","author":"Ulrich","year":"2010","journal-title":"Chirurg"},{"key":"B5","doi-asserted-by":"publisher","first-page":"1818","DOI":"10.1007\/s00464-007-9706-x","article-title":"Endoscopic vacuum-assisted closure of anastomotic leakage following anterior resection of the rectum: a new method","volume":"22","author":"Weidenhagen","year":"2008","journal-title":"Surg Endosc"},{"key":"B6","doi-asserted-by":"publisher","first-page":"1277","DOI":"10.1007\/s00268-019-05349-5","article-title":"Comparison between endoscopic vacuum therapy and conventional treatment for leakage after rectal resection","volume":"44","author":"K\u00fchn","year":"2020","journal-title":"World J Surg"},{"key":"B7","doi-asserted-by":"publisher","first-page":"283","DOI":"10.1007\/s00384-021-04066-7","article-title":"Endoscopic\u00a0vacuum therapy for the treatment of colorectal leaks\u2014a systematic review and meta-analysis","volume":"37","author":"K\u00fchn","year":"2022","journal-title":"Int J Colorectal Dis"},{"key":"B8","doi-asserted-by":"publisher","first-page":"2049","DOI":"10.1007\/s00384-022-04240-5","article-title":"International expert opinion on optimal treatment of anastomotic leakage after rectal cancer resection: a case-vignette study","volume":"37","author":"Talboom","year":"2022","journal-title":"Int J Colorectal Dis"}],"container-title":["Frontiers in Surgery"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fsurg.2022.1099549\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,2,13]],"date-time":"2023-02-13T05:25:52Z","timestamp":1676265952000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fsurg.2022.1099549\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,13]]},"references-count":8,"alternative-id":["10.3389\/fsurg.2022.1099549"],"URL":"https:\/\/doi.org\/10.3389\/fsurg.2022.1099549","relation":{},"ISSN":["2296-875X"],"issn-type":[{"value":"2296-875X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,13]]},"article-number":"1099549"}}