Bonuan Yao, Yunqiang Chen, Hongbo Chen, Xuxia Feng, Xiaojie Ma
{"title":"基于ERAS概念的术后康复在胰十二指肠切除术患者中的作用研究：随机对照临床试验方案","authors":"Bonuan Yao, Yunqiang Chen, Hongbo Chen, Xuxia Feng, Xiaojie Ma","doi":"10.17219/acem/189583","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Pancreaticoduodenectomy (PD), an abdominal surgery, is known for its complexity, cost and inherent risks. Recently, there has been increasing interest in enhanced recovery after surgery (ERAS) as a therapeutic approach. However, the mechanisms underlying postoperative functional recovery remain uncertain, and there are limited data on the efficacy of ERAS in postoperative physiotherapy following complex PD.</p><p><strong>Objectives: </strong>This study aims to examine the feasibility and effectiveness of conducting a large powered randomized controlled trial (RCT) to evaluate a 2-week postoperative rehabilitation program based on the ERAS concept for patients undergoing pancreaticoduodenectomy.</p><p><strong>Material and methods: </strong>This study is a RCT with a single treatment group. From June 2022 to June 2024, 28 PD patients will participate in the trial. Patients will be randomly assigned to either a control group receiving standard clinical care or an intervention group undergoing a 2-week postoperative rehabilitation program. Cardiopulmonary function will be assessed using the 6-minute walk test (6MWT), and gastrointestinal (GI) recovery will be evaluated using the Intake, Feeling nausea, Emesis, physical Exam, and Duration of symptoms (I-FEED) scoring system.</p><p><strong>Results: </strong>Secondary outcomes, including changes in recovery quality post-surgery, will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) and the Quality of Recovery Questionnaire (QOR-40). Additional recorded items will include time to first flatus and feces, daily volume of stomach fluid, time to gastric tube removal, length of hospital stay (LOS), and postoperative complications.</p><p><strong>Conclusion: </strong>The study will utilize the I-FEED score, a novel tool for assessing GI function, to monitor the impact of a 2-week postoperative rehabilitation exercise program on patients. The primary outcome will focus on improvements in cardiopulmonary capacity following postoperative rehabilitation activities.</p>","PeriodicalId":7306,"journal":{"name":"Advances in Clinical and Experimental Medicine","volume":" ","pages":""},"PeriodicalIF":2.1000,"publicationDate":"2024-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Study on the role of postoperative rehabilitation based on the ERAS concept for patients undergoing pancreaticoduodenectomy: Protocol for a randomized controlled clinical trial.\",\"authors\":\"Bonuan Yao, Yunqiang Chen, Hongbo Chen, Xuxia Feng, Xiaojie Ma\",\"doi\":\"10.17219/acem/189583\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Pancreaticoduodenectomy (PD), an abdominal surgery, is known for its complexity, cost and inherent risks. Recently, there has been increasing interest in enhanced recovery after surgery (ERAS) as a therapeutic approach. However, the mechanisms underlying postoperative functional recovery remain uncertain, and there are limited data on the efficacy of ERAS in postoperative physiotherapy following complex PD.</p><p><strong>Objectives: </strong>This study aims to examine the feasibility and effectiveness of conducting a large powered randomized controlled trial (RCT) to evaluate a 2-week postoperative rehabilitation program based on the ERAS concept for patients undergoing pancreaticoduodenectomy.</p><p><strong>Material and methods: </strong>This study is a RCT with a single treatment group. From June 2022 to June 2024, 28 PD patients will participate in the trial. Patients will be randomly assigned to either a control group receiving standard clinical care or an intervention group undergoing a 2-week postoperative rehabilitation program. Cardiopulmonary function will be assessed using the 6-minute walk test (6MWT), and gastrointestinal (GI) recovery will be evaluated using the Intake, Feeling nausea, Emesis, physical Exam, and Duration of symptoms (I-FEED) scoring system.</p><p><strong>Results: </strong>Secondary outcomes, including changes in recovery quality post-surgery, will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) and the Quality of Recovery Questionnaire (QOR-40). Additional recorded items will include time to first flatus and feces, daily volume of stomach fluid, time to gastric tube removal, length of hospital stay (LOS), and postoperative complications.</p><p><strong>Conclusion: </strong>The study will utilize the I-FEED score, a novel tool for assessing GI function, to monitor the impact of a 2-week postoperative rehabilitation exercise program on patients. 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Study on the role of postoperative rehabilitation based on the ERAS concept for patients undergoing pancreaticoduodenectomy: Protocol for a randomized controlled clinical trial.
Background: Pancreaticoduodenectomy (PD), an abdominal surgery, is known for its complexity, cost and inherent risks. Recently, there has been increasing interest in enhanced recovery after surgery (ERAS) as a therapeutic approach. However, the mechanisms underlying postoperative functional recovery remain uncertain, and there are limited data on the efficacy of ERAS in postoperative physiotherapy following complex PD.
Objectives: This study aims to examine the feasibility and effectiveness of conducting a large powered randomized controlled trial (RCT) to evaluate a 2-week postoperative rehabilitation program based on the ERAS concept for patients undergoing pancreaticoduodenectomy.
Material and methods: This study is a RCT with a single treatment group. From June 2022 to June 2024, 28 PD patients will participate in the trial. Patients will be randomly assigned to either a control group receiving standard clinical care or an intervention group undergoing a 2-week postoperative rehabilitation program. Cardiopulmonary function will be assessed using the 6-minute walk test (6MWT), and gastrointestinal (GI) recovery will be evaluated using the Intake, Feeling nausea, Emesis, physical Exam, and Duration of symptoms (I-FEED) scoring system.
Results: Secondary outcomes, including changes in recovery quality post-surgery, will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) and the Quality of Recovery Questionnaire (QOR-40). Additional recorded items will include time to first flatus and feces, daily volume of stomach fluid, time to gastric tube removal, length of hospital stay (LOS), and postoperative complications.
Conclusion: The study will utilize the I-FEED score, a novel tool for assessing GI function, to monitor the impact of a 2-week postoperative rehabilitation exercise program on patients. The primary outcome will focus on improvements in cardiopulmonary capacity following postoperative rehabilitation activities.
期刊介绍：
Advances in Clinical and Experimental Medicine has been published by the Wroclaw Medical University since 1992. Establishing the medical journal was the idea of Prof. Bogumił Halawa, Chair of the Department of Cardiology, and was fully supported by the Rector of Wroclaw Medical University, Prof. Zbigniew Knapik. Prof. Halawa was also the first editor-in-chief, between 1992-1997. The journal, then entitled "Postępy Medycyny Klinicznej i Doświadczalnej", appeared quarterly.
Prof. Leszek Paradowski was editor-in-chief from 1997-1999. In 1998 he initiated alterations in the profile and cover design of the journal which were accepted by the Editorial Board. The title was changed to Advances in Clinical and Experimental Medicine. Articles in English were welcomed. A number of outstanding representatives of medical science from Poland and abroad were invited to participate in the newly established International Editorial Staff.
Prof. Antonina Harłozińska-Szmyrka was editor-in-chief in years 2000-2005, in years 2006-2007 once again prof. Leszek Paradowski and prof. Maria Podolak-Dawidziak was editor-in-chief in years 2008-2016. Since 2017 the editor-in chief is prof. Maciej Bagłaj.
Since July 2005, original papers have been published only in English. Case reports are no longer accepted. The manuscripts are reviewed by two independent reviewers and a statistical reviewer, and English texts are proofread by a native speaker.
The journal has been indexed in several databases: Scopus, Ulrich’sTM International Periodicals Directory, Index Copernicus and since 2007 in Thomson Reuters databases: Science Citation Index Expanded i Journal Citation Reports/Science Edition.
In 2010 the journal obtained Impact Factor which is now 1.179 pts. Articles published in the journal are worth 15 points among Polish journals according to the Polish Committee for Scientific Research and 169.43 points according to the Index Copernicus.
Since November 7, 2012, Advances in Clinical and Experimental Medicine has been indexed and included in National Library of Medicine’s MEDLINE database. English abstracts printed in the journal are included and searchable using PubMed http://www.ncbi.nlm.nih.gov/pubmed.
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