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The efficacy of Enhanced Recovery after Surgery (ERAS) for elderly patients with intertrochanteric fractures who received surgery: study protocol for a randomized, blinded, controlled trial
BACKGROUND: Intertrochanteric fracture (ITF) is increasing with the rapid increase in the aging population, often causes a high mortality rate in old patients and increases the economic burden of the family and society. ERAS (Enhanced Recovery after Surgery) is a powerful guarantee for patients to a...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7057568/ https://www.ncbi.nlm.nih.gov/pubmed/32138760 http://dx.doi.org/10.1186/s13018-020-01586-w |
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author | Yin, Mengchen Yan, Yinjie Fan, Zhaoxiang Fang, Niankang Wan, Hongbo Mo, Wen Wu, Xuequn |
author_facet | Yin, Mengchen Yan, Yinjie Fan, Zhaoxiang Fang, Niankang Wan, Hongbo Mo, Wen Wu, Xuequn |
author_sort | Yin, Mengchen |
collection | PubMed |
description | BACKGROUND: Intertrochanteric fracture (ITF) is increasing with the rapid increase in the aging population, often causes a high mortality rate in old patients and increases the economic burden of the family and society. ERAS (Enhanced Recovery after Surgery) is a powerful guarantee for patients to accelerate their recovery after surgery. TCM (traditional Chinese medicine) promotes repair of injured tissues and eliminates traumatic aseptic inflammation. Therefore, this prospective randomized controlled clinical trial aims to evaluate the clinical effect of the evidence-based ERAS pathway of integrating TCM with western medicine on perioperative outcomes in ITF patients undergoing intramedullary fixation and provide reliable evidence-based data for applying the program to clinical practice. METHODS/DESIGN: We will conduct a prospective randomized, blinded, controlled trial to compare the effectiveness of ERAS care pathway with traditional care pathway and to investigate whether the ERAS care pathway can improve the perioperative outcome in ITF patients undergoing intramedullary fixation. A total of 60 patients with ITF will be enrolled and treated with the two care pathway, respectively. Length of stay, economic indicators, Harris score, VAS score, time to get out of bed, 30-day readmission rates, postoperative transfusion rates, discharge to home, and mortality will be evaluated. Any signs of acute adverse reactions will be recorded at each visit during treatment. DISCUSSION: Although an evidence-based process using the best available literature and Delphi expert-opinion method has been used to establish an ERAS pathway of integrating TCM with western medicine, there is a lack of consensus about its effectiveness. This trial will provide convincing evidence about the effect of ERAS pathway. TRIAL REGISTRATION: Registered on 12 October 2019. Trial number is ChiCTR1900026487. |
format | Online Article Text |
id | pubmed-7057568 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-70575682020-03-10 The efficacy of Enhanced Recovery after Surgery (ERAS) for elderly patients with intertrochanteric fractures who received surgery: study protocol for a randomized, blinded, controlled trial Yin, Mengchen Yan, Yinjie Fan, Zhaoxiang Fang, Niankang Wan, Hongbo Mo, Wen Wu, Xuequn J Orthop Surg Res Study Protocol BACKGROUND: Intertrochanteric fracture (ITF) is increasing with the rapid increase in the aging population, often causes a high mortality rate in old patients and increases the economic burden of the family and society. ERAS (Enhanced Recovery after Surgery) is a powerful guarantee for patients to accelerate their recovery after surgery. TCM (traditional Chinese medicine) promotes repair of injured tissues and eliminates traumatic aseptic inflammation. Therefore, this prospective randomized controlled clinical trial aims to evaluate the clinical effect of the evidence-based ERAS pathway of integrating TCM with western medicine on perioperative outcomes in ITF patients undergoing intramedullary fixation and provide reliable evidence-based data for applying the program to clinical practice. METHODS/DESIGN: We will conduct a prospective randomized, blinded, controlled trial to compare the effectiveness of ERAS care pathway with traditional care pathway and to investigate whether the ERAS care pathway can improve the perioperative outcome in ITF patients undergoing intramedullary fixation. A total of 60 patients with ITF will be enrolled and treated with the two care pathway, respectively. Length of stay, economic indicators, Harris score, VAS score, time to get out of bed, 30-day readmission rates, postoperative transfusion rates, discharge to home, and mortality will be evaluated. Any signs of acute adverse reactions will be recorded at each visit during treatment. DISCUSSION: Although an evidence-based process using the best available literature and Delphi expert-opinion method has been used to establish an ERAS pathway of integrating TCM with western medicine, there is a lack of consensus about its effectiveness. This trial will provide convincing evidence about the effect of ERAS pathway. TRIAL REGISTRATION: Registered on 12 October 2019. Trial number is ChiCTR1900026487. BioMed Central 2020-03-05 /pmc/articles/PMC7057568/ /pubmed/32138760 http://dx.doi.org/10.1186/s13018-020-01586-w Text en © The Author(s) 2020 Open AccessThis 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 Yin, Mengchen Yan, Yinjie Fan, Zhaoxiang Fang, Niankang Wan, Hongbo Mo, Wen Wu, Xuequn The efficacy of Enhanced Recovery after Surgery (ERAS) for elderly patients with intertrochanteric fractures who received surgery: study protocol for a randomized, blinded, controlled trial |
title | The efficacy of Enhanced Recovery after Surgery (ERAS) for elderly patients with intertrochanteric fractures who received surgery: study protocol for a randomized, blinded, controlled trial |
title_full | The efficacy of Enhanced Recovery after Surgery (ERAS) for elderly patients with intertrochanteric fractures who received surgery: study protocol for a randomized, blinded, controlled trial |
title_fullStr | The efficacy of Enhanced Recovery after Surgery (ERAS) for elderly patients with intertrochanteric fractures who received surgery: study protocol for a randomized, blinded, controlled trial |
title_full_unstemmed | The efficacy of Enhanced Recovery after Surgery (ERAS) for elderly patients with intertrochanteric fractures who received surgery: study protocol for a randomized, blinded, controlled trial |
title_short | The efficacy of Enhanced Recovery after Surgery (ERAS) for elderly patients with intertrochanteric fractures who received surgery: study protocol for a randomized, blinded, controlled trial |
title_sort | efficacy of enhanced recovery after surgery (eras) for elderly patients with intertrochanteric fractures who received surgery: study protocol for a randomized, blinded, controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7057568/ https://www.ncbi.nlm.nih.gov/pubmed/32138760 http://dx.doi.org/10.1186/s13018-020-01586-w |
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