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The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial

BACKGROUND: After major abdominal surgery (MAS), 20 % of patients endure major complications, which require invasive treatment and are associated with increased morbidity and mortality. A quality control algorithm after major abdominal surgery aimed at early identification of patients at risk of dev...

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Autores principales: Straatman, Jennifer, Cuesta, Miguel A., Schreurs, W. H. (Hermien), Dwars, Boudewijn J., Cense, Huib A., Rijna, Herman, Sonneveld, D. J. A. (Eric), den Boer, Frank C., de Lange- de Klerk, Elly S. M., van der Peet, Donald L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4552415/
https://www.ncbi.nlm.nih.gov/pubmed/26314740
http://dx.doi.org/10.1186/s13063-015-0903-y
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author Straatman, Jennifer
Cuesta, Miguel A.
Schreurs, W. H. (Hermien)
Dwars, Boudewijn J.
Cense, Huib A.
Rijna, Herman
Sonneveld, D. J. A. (Eric)
den Boer, Frank C.
de Lange- de Klerk, Elly S. M.
van der Peet, Donald L.
author_facet Straatman, Jennifer
Cuesta, Miguel A.
Schreurs, W. H. (Hermien)
Dwars, Boudewijn J.
Cense, Huib A.
Rijna, Herman
Sonneveld, D. J. A. (Eric)
den Boer, Frank C.
de Lange- de Klerk, Elly S. M.
van der Peet, Donald L.
author_sort Straatman, Jennifer
collection PubMed
description BACKGROUND: After major abdominal surgery (MAS), 20 % of patients endure major complications, which require invasive treatment and are associated with increased morbidity and mortality. A quality control algorithm after major abdominal surgery aimed at early identification of patients at risk of developing major complications can decrease associated morbidity and mortality. Literature studies show promising results for C-reactive protein (CRP) as an early marker for postoperative complications, however clinical significance has yet to be determined. METHODS: A multicenter, stepped wedge, prospective clinical trial including all adult patients planned to undergo elective MAS. The first period consists of standard postoperative monitoring, which entails on demand additional examinations. This is followed by a period with implementation of postoperative control according to the PRECious protocol, which implicates standardized measurement of CRP levels. If CRP levels exceed 140 mg/L on postoperative day 3,4 or 5, an enhanced CT-scan is performed. Primary outcome in this study is a combined primary outcome, entailing all morbidity and mortality due to postoperative complications. Complications are graded according to the Clavien-Dindo classification. Secondary outcomes are hospital length of stay, patients reported outcome measures (PROMs) and cost-effectiveness. Data will be collected during admission, three months and one year postoperatively. Approval by the medical ethics committee of the VU University Medical Center was obtained (ID 2015.114). DISCUSSION: the PRECious trial is a stepped-wedge, multicenter, open label, prospective clinical trial to determine the effect of a standardized postoperative quality control algorithm on postoperative morbidity and mortality, and cost-effectiveness. TRIAL REGISTRATION: www.ClinicalTrials.gov, NCT02102217. Registered 5 February 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0903-y) contains supplementary material, which is available to authorized users.
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spelling pubmed-45524152015-08-29 The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial Straatman, Jennifer Cuesta, Miguel A. Schreurs, W. H. (Hermien) Dwars, Boudewijn J. Cense, Huib A. Rijna, Herman Sonneveld, D. J. A. (Eric) den Boer, Frank C. de Lange- de Klerk, Elly S. M. van der Peet, Donald L. Trials Study Protocol BACKGROUND: After major abdominal surgery (MAS), 20 % of patients endure major complications, which require invasive treatment and are associated with increased morbidity and mortality. A quality control algorithm after major abdominal surgery aimed at early identification of patients at risk of developing major complications can decrease associated morbidity and mortality. Literature studies show promising results for C-reactive protein (CRP) as an early marker for postoperative complications, however clinical significance has yet to be determined. METHODS: A multicenter, stepped wedge, prospective clinical trial including all adult patients planned to undergo elective MAS. The first period consists of standard postoperative monitoring, which entails on demand additional examinations. This is followed by a period with implementation of postoperative control according to the PRECious protocol, which implicates standardized measurement of CRP levels. If CRP levels exceed 140 mg/L on postoperative day 3,4 or 5, an enhanced CT-scan is performed. Primary outcome in this study is a combined primary outcome, entailing all morbidity and mortality due to postoperative complications. Complications are graded according to the Clavien-Dindo classification. Secondary outcomes are hospital length of stay, patients reported outcome measures (PROMs) and cost-effectiveness. Data will be collected during admission, three months and one year postoperatively. Approval by the medical ethics committee of the VU University Medical Center was obtained (ID 2015.114). DISCUSSION: the PRECious trial is a stepped-wedge, multicenter, open label, prospective clinical trial to determine the effect of a standardized postoperative quality control algorithm on postoperative morbidity and mortality, and cost-effectiveness. TRIAL REGISTRATION: www.ClinicalTrials.gov, NCT02102217. Registered 5 February 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0903-y) contains supplementary material, which is available to authorized users. BioMed Central 2015-08-28 /pmc/articles/PMC4552415/ /pubmed/26314740 http://dx.doi.org/10.1186/s13063-015-0903-y Text en © Straatman et al. 2015 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Straatman, Jennifer
Cuesta, Miguel A.
Schreurs, W. H. (Hermien)
Dwars, Boudewijn J.
Cense, Huib A.
Rijna, Herman
Sonneveld, D. J. A. (Eric)
den Boer, Frank C.
de Lange- de Klerk, Elly S. M.
van der Peet, Donald L.
The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial
title The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial
title_full The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial
title_fullStr The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial
title_full_unstemmed The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial
title_short The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial
title_sort precious trial prediction of complications, a step-up approach, crp first followed by ct-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4552415/
https://www.ncbi.nlm.nih.gov/pubmed/26314740
http://dx.doi.org/10.1186/s13063-015-0903-y
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