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Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial

BACKGROUND: Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal can...

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Autores principales: Löffler, Thorsten, Seiler, Christoph M, Rossion, Inga, Kijak, Thomas, Thomusch, Oliver, Hodina, Renè, Krüger, Matthias, Simon, Thomas, Bruckner, Thomas, Kieser, Meinhard, Büchler, Markus W, Weitz, Jürgen
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3042950/
https://www.ncbi.nlm.nih.gov/pubmed/21303515
http://dx.doi.org/10.1186/1745-6215-12-34
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author Löffler, Thorsten
Seiler, Christoph M
Rossion, Inga
Kijak, Thomas
Thomusch, Oliver
Hodina, Renè
Krüger, Matthias
Simon, Thomas
Bruckner, Thomas
Kieser, Meinhard
Büchler, Markus W
Weitz, Jürgen
author_facet Löffler, Thorsten
Seiler, Christoph M
Rossion, Inga
Kijak, Thomas
Thomusch, Oliver
Hodina, Renè
Krüger, Matthias
Simon, Thomas
Bruckner, Thomas
Kieser, Meinhard
Büchler, Markus W
Weitz, Jürgen
author_sort Löffler, Thorsten
collection PubMed
description BACKGROUND: Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet. METHODS/DESIGN: A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer. The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol. DISCUSSION: Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for closure of loop ileostomy in patients with rectal cancer. TRIAL REGISTRATION: German Clinical Trial Register Number: DRKS00000040
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spelling pubmed-30429502011-02-23 Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial Löffler, Thorsten Seiler, Christoph M Rossion, Inga Kijak, Thomas Thomusch, Oliver Hodina, Renè Krüger, Matthias Simon, Thomas Bruckner, Thomas Kieser, Meinhard Büchler, Markus W Weitz, Jürgen Trials Study Protocol BACKGROUND: Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet. METHODS/DESIGN: A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer. The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol. DISCUSSION: Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for closure of loop ileostomy in patients with rectal cancer. TRIAL REGISTRATION: German Clinical Trial Register Number: DRKS00000040 BioMed Central 2011-02-08 /pmc/articles/PMC3042950/ /pubmed/21303515 http://dx.doi.org/10.1186/1745-6215-12-34 Text en Copyright ©2011 Löffler et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Löffler, Thorsten
Seiler, Christoph M
Rossion, Inga
Kijak, Thomas
Thomusch, Oliver
Hodina, Renè
Krüger, Matthias
Simon, Thomas
Bruckner, Thomas
Kieser, Meinhard
Büchler, Markus W
Weitz, Jürgen
Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial
title Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial
title_full Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial
title_fullStr Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial
title_full_unstemmed Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial
title_short Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial
title_sort hand-suture versus stapling for closure of loop ileostomy: hasta-trial: a study rationale and design for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3042950/
https://www.ncbi.nlm.nih.gov/pubmed/21303515
http://dx.doi.org/10.1186/1745-6215-12-34
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