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Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial

INTRODUCTION: Performing bariatric surgery in a daycare setting has a potential reduction in hospital costs and increase in patients’ satisfaction. Although the feasibility and safety of such care pathway has already been proven, its implementation is hampered by concerns about timely detection of s...

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Autores principales: Scheerhoorn, Jai, van Ede, Lisa, Luyer, Misha D. P., Buise, Marc P., Bouwman, R. Arthur, Nienhuijs, Simon W.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8781161/
https://www.ncbi.nlm.nih.gov/pubmed/35063007
http://dx.doi.org/10.1186/s13063-022-06001-9
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author Scheerhoorn, Jai
van Ede, Lisa
Luyer, Misha D. P.
Buise, Marc P.
Bouwman, R. Arthur
Nienhuijs, Simon W.
author_facet Scheerhoorn, Jai
van Ede, Lisa
Luyer, Misha D. P.
Buise, Marc P.
Bouwman, R. Arthur
Nienhuijs, Simon W.
author_sort Scheerhoorn, Jai
collection PubMed
description INTRODUCTION: Performing bariatric surgery in a daycare setting has a potential reduction in hospital costs and increase in patients’ satisfaction. Although the feasibility and safety of such care pathway has already been proven, its implementation is hampered by concerns about timely detection of short-term complications. This study is designed to evaluate a combined outcome measurement in outpatient bariatric surgery supplemented by a novel wireless remote monitoring system versus current standard of care. METHODS AND ANALYSIS: A total of 200 patients with multidisciplinary team approval for primary bariatric surgery will be assigned based on their preference to one of two postoperative trajectories: (1) standard of in-hospital care with discharge on the first postoperative day or (2) same day discharge with ongoing telemonitoring up to 7 days after surgery. The device (Healthdot R Philips) transfers heart rate, respiration rate, activity, and body posture of the patient continuously by LoRaWan network to our hospital’s dashboard (Philips Guardian). The primary outcome is a composite outcome measure within 30 days postoperative based on mortality, mild and severe complications, readmission, and prolonged length-of-stay. Secondary outcomes include patients’ satisfaction and data handling dimensions. TRIAL REGISTRATION: ClinicalTrials.govNCT04754893, Registered on 12 February 2021.
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spelling pubmed-87811612022-01-21 Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial Scheerhoorn, Jai van Ede, Lisa Luyer, Misha D. P. Buise, Marc P. Bouwman, R. Arthur Nienhuijs, Simon W. Trials Study Protocol INTRODUCTION: Performing bariatric surgery in a daycare setting has a potential reduction in hospital costs and increase in patients’ satisfaction. Although the feasibility and safety of such care pathway has already been proven, its implementation is hampered by concerns about timely detection of short-term complications. This study is designed to evaluate a combined outcome measurement in outpatient bariatric surgery supplemented by a novel wireless remote monitoring system versus current standard of care. METHODS AND ANALYSIS: A total of 200 patients with multidisciplinary team approval for primary bariatric surgery will be assigned based on their preference to one of two postoperative trajectories: (1) standard of in-hospital care with discharge on the first postoperative day or (2) same day discharge with ongoing telemonitoring up to 7 days after surgery. The device (Healthdot R Philips) transfers heart rate, respiration rate, activity, and body posture of the patient continuously by LoRaWan network to our hospital’s dashboard (Philips Guardian). The primary outcome is a composite outcome measure within 30 days postoperative based on mortality, mild and severe complications, readmission, and prolonged length-of-stay. Secondary outcomes include patients’ satisfaction and data handling dimensions. TRIAL REGISTRATION: ClinicalTrials.govNCT04754893, Registered on 12 February 2021. BioMed Central 2022-01-21 /pmc/articles/PMC8781161/ /pubmed/35063007 http://dx.doi.org/10.1186/s13063-022-06001-9 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Scheerhoorn, Jai
van Ede, Lisa
Luyer, Misha D. P.
Buise, Marc P.
Bouwman, R. Arthur
Nienhuijs, Simon W.
Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial
title Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial
title_full Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial
title_fullStr Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial
title_full_unstemmed Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial
title_short Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial
title_sort postbariatric early discharge controlled by healthdot (peach) trial: study protocol for a preference-based randomized trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8781161/
https://www.ncbi.nlm.nih.gov/pubmed/35063007
http://dx.doi.org/10.1186/s13063-022-06001-9
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