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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
BACKGROUND: 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,...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9968789/ https://www.ncbi.nlm.nih.gov/pubmed/36860727 http://dx.doi.org/10.3389/fsurg.2022.1099549 |
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author | 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 |
author_facet | 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 |
author_sort | Schiffmann, Leif |
collection | PubMed |
description | BACKGROUND: 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. METHODS: 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%. DISCUSSION: If the hypothesis proves to be true, anastomosis leakage could be reduced significantly by placing a vacuum sponge over the anastomosis for 5 days. TRIAL REGISTRATION: 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. |
format | Online Article Text |
id | pubmed-9968789 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-99687892023-02-28 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 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 Front Surg Surgery BACKGROUND: 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. METHODS: 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%. DISCUSSION: If the hypothesis proves to be true, anastomosis leakage could be reduced significantly by placing a vacuum sponge over the anastomosis for 5 days. TRIAL REGISTRATION: 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. Frontiers Media S.A. 2023-02-13 /pmc/articles/PMC9968789/ /pubmed/36860727 http://dx.doi.org/10.3389/fsurg.2022.1099549 Text en © 2023 Schiffmann, Becker, Develing, Varga-Szabo, Scheidereiter-Krüger, Zirngibl, Seifert, Biermann, Schlüter, Tumczak, Weimann, Jansen-Winkeln, Wallstabe, Schwandner, Denecke, Schafmayer, Kamaleddine, Stier, Haegele, Kindler, Michling, Horling and Denzer. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) (https://creativecommons.org/licenses/by/4.0/) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Surgery 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 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Surgery |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9968789/ https://www.ncbi.nlm.nih.gov/pubmed/36860727 http://dx.doi.org/10.3389/fsurg.2022.1099549 |
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