SEVTAR-A multicenter randomized controlled trial to investigate the impact of prophylactic endoluminal placed vacuum sponge for prevention of anastomotic leakage after low rectal resections

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...

Full description

Saved in:

Bibliographic Details
Published in:	Frontiers in surgery Vol. 9; p. 1099549
Main Authors:	Schiffmann, Leif, Becker, Matthias, Develing, Leendert, Varga-Szabo, David, Scheidereiter-Krüger, Caroline, Zirngibl, Hubert, Seifert, Michael, Biermann, Lothar, Schlüter, Claudia, Tumczak, Felicitas, Weimann, Arved, Jansen-Winkeln, Boris, Wallstabe, Ingo, Schwandner, Frank, Denecke, Sandra, Schafmayer, Clemens, Kamaleddine, Imad, Stier, Albrecht, Haegele, Katharina, Kindler, Michael, Michling, Sabine, Horling, Ernst-Wilhelm, Denzer, Ulrike
Format:	Journal Article
Language:	English
Published:	Switzerland Frontiers Media S.A 13-02-2023
Subjects:	anastomotic leakage prevention randomized trial rectal cancer SEVTAR study Surgery SEVTAR study randomized trial prevention anastomotic leakage rectal cancer
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	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. 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 cm 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%-15%. If the hypothesis proves to be true, anastomosis leakage could be reduced significantly by placing a vacuum sponge over the anastomosis for 5 days. 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 2019-0203.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Specialty Section: This article was submitted to Visceral Surgery, a section of the journal Frontiers in Surgery Edited by: Gabriel Sandblom, Karolinska Institutet (KI), Sweden Reviewed by: Michael Solomon, The University of Sydney, Australia Marco Frascio, University of Genoa, Italy
ISSN:	2296-875X 2296-875X
DOI:	10.3389/fsurg.2022.1099549