Effect of Enhanced Recovery After Surgery program on pancreaticoduodenectomy: a randomized controlled trial

Background This study aims to investigate the noninferiority of Enhanced Recovery After Surgery (ERAS) for pancreaticoduodenectomy (PD). Methods In this single‐center trial, we randomly assigned 276 adult patients who underwent open PD into ERAS and conventional groups with 138 patients in each, fro...

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Veröffentlicht in:Journal of hepato-biliary-pancreatic sciences 2019-08, Vol.26 (8), p.360-369
Hauptverfasser: Hwang, Dae Wook, Kim, Hwa Jung, Lee, Jae Hoon, Song, Ki Byung, Kim, Myeong‐Hwan, Lee, Sung Koo, Choi, Kyu Taek, Jun, In‐Gu, Bang, Ji‐Yeon, Kim, Song Cheol
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container_end_page 369
container_issue 8
container_start_page 360
container_title Journal of hepato-biliary-pancreatic sciences
container_volume 26
creator Hwang, Dae Wook
Kim, Hwa Jung
Lee, Jae Hoon
Song, Ki Byung
Kim, Myeong‐Hwan
Lee, Sung Koo
Choi, Kyu Taek
Jun, In‐Gu
Bang, Ji‐Yeon
Kim, Song Cheol
description Background This study aims to investigate the noninferiority of Enhanced Recovery After Surgery (ERAS) for pancreaticoduodenectomy (PD). Methods In this single‐center trial, we randomly assigned 276 adult patients who underwent open PD into ERAS and conventional groups with 138 patients in each, from 2015 through 2017. The primary endpoint was the incidence of overall morbidity until postoperative 3 months. The secondary endpoints were in‐hospital or 30‐day mortality, postoperative length of stay (LOS), nutritional status and overall hospital costs. Results Overall morbidity was reported in 64 patients (52.0%, ERAS group) and in 68 patients (54.8%, conventional group) (risk difference [RD] −2.81 percentage points (pp); 90% two‐sided confidence interval −13.24 to 7.63). Mortality did not occur in any patients. The two groups did not differ significantly in median postoperative LOS (both 11 days; RD −8.46 pp), body mass index (22.4 ± 2.75 vs. 22.4 ± 2.65 kg/m2; RD −3.48 pp), Patient‐Generated Subjective Global Assessment score over 4 (45 [40.5%] vs. 50 [43.1%] patients; RD −2.56 pp), and median overall hospital cost (15.61 vs. 16.04, ×106 KRW; RD −6.08 pp). Conclusions Even in PD, modified ERAS protocol was not inferior to conventional protocol, while reducing treatment burden. Highlight This randomized clinical trial by Hwang and colleagues revealed that the Enhanced Recovery After Surgery (ERAS) protocol was not inferior to the conventional perioperative management protocol for pancreaticoduodenectomy regarding morbidity, mortality, length of stay and hospital cost. The ERAS protocol not only reduces treatment burden, but also facilitates treatment administration.
doi_str_mv 10.1002/jhbp.641
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Methods In this single‐center trial, we randomly assigned 276 adult patients who underwent open PD into ERAS and conventional groups with 138 patients in each, from 2015 through 2017. The primary endpoint was the incidence of overall morbidity until postoperative 3 months. The secondary endpoints were in‐hospital or 30‐day mortality, postoperative length of stay (LOS), nutritional status and overall hospital costs. Results Overall morbidity was reported in 64 patients (52.0%, ERAS group) and in 68 patients (54.8%, conventional group) (risk difference [RD] −2.81 percentage points (pp); 90% two‐sided confidence interval −13.24 to 7.63). Mortality did not occur in any patients. The two groups did not differ significantly in median postoperative LOS (both 11 days; RD −8.46 pp), body mass index (22.4 ± 2.75 vs. 22.4 ± 2.65 kg/m2; RD −3.48 pp), Patient‐Generated Subjective Global Assessment score over 4 (45 [40.5%] vs. 50 [43.1%] patients; RD −2.56 pp), and median overall hospital cost (15.61 vs. 16.04, ×106 KRW; RD −6.08 pp). Conclusions Even in PD, modified ERAS protocol was not inferior to conventional protocol, while reducing treatment burden. Highlight This randomized clinical trial by Hwang and colleagues revealed that the Enhanced Recovery After Surgery (ERAS) protocol was not inferior to the conventional perioperative management protocol for pancreaticoduodenectomy regarding morbidity, mortality, length of stay and hospital cost. The ERAS protocol not only reduces treatment burden, but also facilitates treatment administration.</description><identifier>ISSN: 1868-6974</identifier><identifier>EISSN: 1868-6982</identifier><identifier>DOI: 10.1002/jhbp.641</identifier><identifier>PMID: 31152686</identifier><language>eng</language><publisher>Japan: Wiley Subscription Services, Inc</publisher><subject>Academic Medical Centers ; Adult ; Aged ; Enhanced Recovery After Surgery ; Fast track ; Follow-Up Studies ; Hospital costs ; Humans ; Middle Aged ; Mortality ; Multivariate Analysis ; Pancreatic Neoplasms - pathology ; Pancreatic Neoplasms - surgery ; Pancreaticoduodenectomy ; Pancreaticoduodenectomy - adverse effects ; Pancreaticoduodenectomy - methods ; Perioperative management ; Postoperative Care - methods ; Postoperative outcomes ; Proportional Hazards Models ; Prospective Studies ; Recovery of Function - physiology ; Republic of Korea ; Risk Assessment ; Statistics, Nonparametric ; Time Factors ; Treatment Outcome</subject><ispartof>Journal of hepato-biliary-pancreatic sciences, 2019-08, Vol.26 (8), p.360-369</ispartof><rights>2019 Japanese Society of Hepato‐Biliary‐Pancreatic Surgery</rights><rights>2019 Japanese Society of Hepato-Biliary-Pancreatic Surgery.</rights><rights>Copyright © 2019 Japanese Society of Hepato‐Biliary‐Pancreatic Surgery</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4391-d93bf0ffbb787c22fcb326ad1422151fc2d6527e67f74d8a74563c906a1a83f23</citedby><cites>FETCH-LOGICAL-c4391-d93bf0ffbb787c22fcb326ad1422151fc2d6527e67f74d8a74563c906a1a83f23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjhbp.641$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjhbp.641$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31152686$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hwang, Dae Wook</creatorcontrib><creatorcontrib>Kim, Hwa Jung</creatorcontrib><creatorcontrib>Lee, Jae Hoon</creatorcontrib><creatorcontrib>Song, Ki Byung</creatorcontrib><creatorcontrib>Kim, Myeong‐Hwan</creatorcontrib><creatorcontrib>Lee, Sung Koo</creatorcontrib><creatorcontrib>Choi, Kyu Taek</creatorcontrib><creatorcontrib>Jun, In‐Gu</creatorcontrib><creatorcontrib>Bang, Ji‐Yeon</creatorcontrib><creatorcontrib>Kim, Song Cheol</creatorcontrib><title>Effect of Enhanced Recovery After Surgery program on pancreaticoduodenectomy: a randomized controlled trial</title><title>Journal of hepato-biliary-pancreatic sciences</title><addtitle>J Hepatobiliary Pancreat Sci</addtitle><description>Background This study aims to investigate the noninferiority of Enhanced Recovery After Surgery (ERAS) for pancreaticoduodenectomy (PD). Methods In this single‐center trial, we randomly assigned 276 adult patients who underwent open PD into ERAS and conventional groups with 138 patients in each, from 2015 through 2017. The primary endpoint was the incidence of overall morbidity until postoperative 3 months. The secondary endpoints were in‐hospital or 30‐day mortality, postoperative length of stay (LOS), nutritional status and overall hospital costs. Results Overall morbidity was reported in 64 patients (52.0%, ERAS group) and in 68 patients (54.8%, conventional group) (risk difference [RD] −2.81 percentage points (pp); 90% two‐sided confidence interval −13.24 to 7.63). Mortality did not occur in any patients. The two groups did not differ significantly in median postoperative LOS (both 11 days; RD −8.46 pp), body mass index (22.4 ± 2.75 vs. 22.4 ± 2.65 kg/m2; RD −3.48 pp), Patient‐Generated Subjective Global Assessment score over 4 (45 [40.5%] vs. 50 [43.1%] patients; RD −2.56 pp), and median overall hospital cost (15.61 vs. 16.04, ×106 KRW; RD −6.08 pp). Conclusions Even in PD, modified ERAS protocol was not inferior to conventional protocol, while reducing treatment burden. Highlight This randomized clinical trial by Hwang and colleagues revealed that the Enhanced Recovery After Surgery (ERAS) protocol was not inferior to the conventional perioperative management protocol for pancreaticoduodenectomy regarding morbidity, mortality, length of stay and hospital cost. 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Methods In this single‐center trial, we randomly assigned 276 adult patients who underwent open PD into ERAS and conventional groups with 138 patients in each, from 2015 through 2017. The primary endpoint was the incidence of overall morbidity until postoperative 3 months. The secondary endpoints were in‐hospital or 30‐day mortality, postoperative length of stay (LOS), nutritional status and overall hospital costs. Results Overall morbidity was reported in 64 patients (52.0%, ERAS group) and in 68 patients (54.8%, conventional group) (risk difference [RD] −2.81 percentage points (pp); 90% two‐sided confidence interval −13.24 to 7.63). Mortality did not occur in any patients. The two groups did not differ significantly in median postoperative LOS (both 11 days; RD −8.46 pp), body mass index (22.4 ± 2.75 vs. 22.4 ± 2.65 kg/m2; RD −3.48 pp), Patient‐Generated Subjective Global Assessment score over 4 (45 [40.5%] vs. 50 [43.1%] patients; RD −2.56 pp), and median overall hospital cost (15.61 vs. 16.04, ×106 KRW; RD −6.08 pp). Conclusions Even in PD, modified ERAS protocol was not inferior to conventional protocol, while reducing treatment burden. Highlight This randomized clinical trial by Hwang and colleagues revealed that the Enhanced Recovery After Surgery (ERAS) protocol was not inferior to the conventional perioperative management protocol for pancreaticoduodenectomy regarding morbidity, mortality, length of stay and hospital cost. The ERAS protocol not only reduces treatment burden, but also facilitates treatment administration.</abstract><cop>Japan</cop><pub>Wiley Subscription Services, Inc</pub><pmid>31152686</pmid><doi>10.1002/jhbp.641</doi><tpages>10</tpages></addata></record>
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source MEDLINE; Wiley Online Library Journals Frontfile Complete
subjects Academic Medical Centers
Adult
Aged
Enhanced Recovery After Surgery
Fast track
Follow-Up Studies
Hospital costs
Humans
Middle Aged
Mortality
Multivariate Analysis
Pancreatic Neoplasms - pathology
Pancreatic Neoplasms - surgery
Pancreaticoduodenectomy
Pancreaticoduodenectomy - adverse effects
Pancreaticoduodenectomy - methods
Perioperative management
Postoperative Care - methods
Postoperative outcomes
Proportional Hazards Models
Prospective Studies
Recovery of Function - physiology
Republic of Korea
Risk Assessment
Statistics, Nonparametric
Time Factors
Treatment Outcome
title Effect of Enhanced Recovery After Surgery program on pancreaticoduodenectomy: a randomized controlled trial
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