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Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the Enhanced Recovery After Surgery (ERAS) Pathway for the Improvement of Postoperative Outcomes: Protocol for a Randomized Controlled Trial

BACKGROUND: A key element in the postoperative phase of the standardized Enhanced Recovery After Surgery (ERAS) treatment pathways is mobilization. Currently, there are no recommendations in the ERAS guidelines for preoperative physical activity. Patients undergoing major surgery are prone to functi...

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Autores principales: Merki-Künzli, Cornelia, Kerstan-Huber, Marta, Switalla, Denise, Gisi, David, Raptis, Dimitri Aristotle, Greco, Nicola, Mungo, Giuseppe, Wirz, Markus, Gloor, Severin, Misirlic, Merima, Breitenstein, Stefan, Tschuor, Christoph
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5681719/
https://www.ncbi.nlm.nih.gov/pubmed/29079551
http://dx.doi.org/10.2196/resprot.7972
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author Merki-Künzli, Cornelia
Kerstan-Huber, Marta
Switalla, Denise
Gisi, David
Raptis, Dimitri Aristotle
Greco, Nicola
Mungo, Giuseppe
Wirz, Markus
Gloor, Severin
Misirlic, Merima
Breitenstein, Stefan
Tschuor, Christoph
author_facet Merki-Künzli, Cornelia
Kerstan-Huber, Marta
Switalla, Denise
Gisi, David
Raptis, Dimitri Aristotle
Greco, Nicola
Mungo, Giuseppe
Wirz, Markus
Gloor, Severin
Misirlic, Merima
Breitenstein, Stefan
Tschuor, Christoph
author_sort Merki-Künzli, Cornelia
collection PubMed
description BACKGROUND: A key element in the postoperative phase of the standardized Enhanced Recovery After Surgery (ERAS) treatment pathways is mobilization. Currently, there are no recommendations in the ERAS guidelines for preoperative physical activity. Patients undergoing major surgery are prone to functional decline due to the impairment of muscle, cardiorespiratory, and neurological function as a response to surgical stress. It has been shown that preoperative physical training reduces postoperative complications. To date, there are limited studies that investigate preoperative physical training combined with ERAS. OBJECTIVE: The aim of this study is to assess the impact of tailored physical training prior to colorectal surgery conducted according to an ERAS protocol on overall morbidity. This study proposes the initial hypothesis that 3-6 weeks of prehabilitation before elective colorectal surgery may improve postoperative outcome and reduce complication rates, assessed using the Comprehensive Complication Index. The primary objective is to evaluate overall morbidity due to postoperative complications. Additionally, complications are assessed according to the Clavien-Dindo classification, length of stay, readmission rate, mortality rate, and treatment-related costs. METHODS: The prehabilitation Enhanced Recovery After colorectal Surgery (pERACS) study is a single-center, single-blinded prospective randomized controlled trial. Patients scheduled for colorectal resections are randomly assigned either to the prehabilitation group or the control group. All patients are treated with the ERAS pathway for colorectal resections according to a standardized study schedule. Sample size calculation performed by estimating a clinically relevant 25% reduction of postoperative complications (alpha=.05, power 80%, dropout rate of 10%) resulted in 56 randomized patients per group. RESULTS: Following ethical approval of the study protocol, the first patient was included in June 2016. At this time, a total of 40 patients have been included; 27 patients terminated the study by the end of March 2017. Results are expected to be published in 2018. CONCLUSIONS: The pERACS trial is a single-center, single-blinded prospective randomized controlled trial to assess the impact of tailored physical training prior to colorectal surgery, conducted according to an ERAS protocol, in order to evaluate overall morbidity. TRIAL REGISTRATION: Clinicaltrials.gov NCT02746731; https://clinicaltrials.gov/ct2/show/NCT02746731 (Archived by WebCite at http://www.webcitation.org/6tzblGwge)
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spelling pubmed-56817192017-11-28 Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the Enhanced Recovery After Surgery (ERAS) Pathway for the Improvement of Postoperative Outcomes: Protocol for a Randomized Controlled Trial Merki-Künzli, Cornelia Kerstan-Huber, Marta Switalla, Denise Gisi, David Raptis, Dimitri Aristotle Greco, Nicola Mungo, Giuseppe Wirz, Markus Gloor, Severin Misirlic, Merima Breitenstein, Stefan Tschuor, Christoph JMIR Res Protoc Protocol BACKGROUND: A key element in the postoperative phase of the standardized Enhanced Recovery After Surgery (ERAS) treatment pathways is mobilization. Currently, there are no recommendations in the ERAS guidelines for preoperative physical activity. Patients undergoing major surgery are prone to functional decline due to the impairment of muscle, cardiorespiratory, and neurological function as a response to surgical stress. It has been shown that preoperative physical training reduces postoperative complications. To date, there are limited studies that investigate preoperative physical training combined with ERAS. OBJECTIVE: The aim of this study is to assess the impact of tailored physical training prior to colorectal surgery conducted according to an ERAS protocol on overall morbidity. This study proposes the initial hypothesis that 3-6 weeks of prehabilitation before elective colorectal surgery may improve postoperative outcome and reduce complication rates, assessed using the Comprehensive Complication Index. The primary objective is to evaluate overall morbidity due to postoperative complications. Additionally, complications are assessed according to the Clavien-Dindo classification, length of stay, readmission rate, mortality rate, and treatment-related costs. METHODS: The prehabilitation Enhanced Recovery After colorectal Surgery (pERACS) study is a single-center, single-blinded prospective randomized controlled trial. Patients scheduled for colorectal resections are randomly assigned either to the prehabilitation group or the control group. All patients are treated with the ERAS pathway for colorectal resections according to a standardized study schedule. Sample size calculation performed by estimating a clinically relevant 25% reduction of postoperative complications (alpha=.05, power 80%, dropout rate of 10%) resulted in 56 randomized patients per group. RESULTS: Following ethical approval of the study protocol, the first patient was included in June 2016. At this time, a total of 40 patients have been included; 27 patients terminated the study by the end of March 2017. Results are expected to be published in 2018. CONCLUSIONS: The pERACS trial is a single-center, single-blinded prospective randomized controlled trial to assess the impact of tailored physical training prior to colorectal surgery, conducted according to an ERAS protocol, in order to evaluate overall morbidity. TRIAL REGISTRATION: Clinicaltrials.gov NCT02746731; https://clinicaltrials.gov/ct2/show/NCT02746731 (Archived by WebCite at http://www.webcitation.org/6tzblGwge) JMIR Publications 2017-10-27 /pmc/articles/PMC5681719/ /pubmed/29079551 http://dx.doi.org/10.2196/resprot.7972 Text en ©Cornelia Merki-Künzli, Marta Kerstan-Huber, Denise Switalla, David Gisi, Dimitri Aristotle Raptis, Nicola Greco, Giuseppe Mungo, Markus Wirz, Severin Gloor, Merima Misirlic, Stefan Breitenstein, Christoph Tschuor. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 27.10.2017. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Merki-Künzli, Cornelia
Kerstan-Huber, Marta
Switalla, Denise
Gisi, David
Raptis, Dimitri Aristotle
Greco, Nicola
Mungo, Giuseppe
Wirz, Markus
Gloor, Severin
Misirlic, Merima
Breitenstein, Stefan
Tschuor, Christoph
Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the Enhanced Recovery After Surgery (ERAS) Pathway for the Improvement of Postoperative Outcomes: Protocol for a Randomized Controlled Trial
title Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the Enhanced Recovery After Surgery (ERAS) Pathway for the Improvement of Postoperative Outcomes: Protocol for a Randomized Controlled Trial
title_full Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the Enhanced Recovery After Surgery (ERAS) Pathway for the Improvement of Postoperative Outcomes: Protocol for a Randomized Controlled Trial
title_fullStr Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the Enhanced Recovery After Surgery (ERAS) Pathway for the Improvement of Postoperative Outcomes: Protocol for a Randomized Controlled Trial
title_full_unstemmed Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the Enhanced Recovery After Surgery (ERAS) Pathway for the Improvement of Postoperative Outcomes: Protocol for a Randomized Controlled Trial
title_short Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the Enhanced Recovery After Surgery (ERAS) Pathway for the Improvement of Postoperative Outcomes: Protocol for a Randomized Controlled Trial
title_sort assessing the value of prehabilitation in patients undergoing colorectal surgery according to the enhanced recovery after surgery (eras) pathway for the improvement of postoperative outcomes: protocol for a randomized controlled trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5681719/
https://www.ncbi.nlm.nih.gov/pubmed/29079551
http://dx.doi.org/10.2196/resprot.7972
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