Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single‐center phase II clinical trial for safety and efficacy

Background We aimed to evaluate the safety and efficacy of a clinical pathway (CP) for enhanced recovery after surgery (ERAS) in gastric cancer patients, including early oral feeding and discharge on postoperative day 4. Methods We performed a prospective, single‐center, phase II clinical trial. Bas...

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Veröffentlicht in:Journal of surgical oncology 2020-03, Vol.121 (4), p.662-669
Hauptverfasser: Roh, Chul Kyu, Son, Sang‐Yong, Lee, Sook Young, Hur, Hoon, Han, Sang‐Uk
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container_end_page 669
container_issue 4
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container_title Journal of surgical oncology
container_volume 121
creator Roh, Chul Kyu
Son, Sang‐Yong
Lee, Sook Young
Hur, Hoon
Han, Sang‐Uk
description Background We aimed to evaluate the safety and efficacy of a clinical pathway (CP) for enhanced recovery after surgery (ERAS) in gastric cancer patients, including early oral feeding and discharge on postoperative day 4. Methods We performed a prospective, single‐center, phase II clinical trial. Based on proposed indications for an ERAS CP in our retrospective study, we enrolled 133 patients younger than 65 years who were undergoing minimally invasive subtotal gastrectomy. The primary endpoint was the ERAS CP completion rate. Secondary endpoints included complication, mortality, hospital stay, and readmission. Results Among 133 patients, six patients were dropped out from this study. The ERAS CP completion rate (77.2%, 98 of 127) was comparable to the historical control group that completed a conventional CP (85.4%, P = .085). The postoperative complication incidence (13.4%, 15 of 127) was also similar to that of the conventional CP group (9.5%, P = .174). We identified reduced hospital stays (4.7 ± 1.3 vs 7.2±2.3 days; P 
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Methods We performed a prospective, single‐center, phase II clinical trial. Based on proposed indications for an ERAS CP in our retrospective study, we enrolled 133 patients younger than 65 years who were undergoing minimally invasive subtotal gastrectomy. The primary endpoint was the ERAS CP completion rate. Secondary endpoints included complication, mortality, hospital stay, and readmission. Results Among 133 patients, six patients were dropped out from this study. The ERAS CP completion rate (77.2%, 98 of 127) was comparable to the historical control group that completed a conventional CP (85.4%, P = .085). The postoperative complication incidence (13.4%, 15 of 127) was also similar to that of the conventional CP group (9.5%, P = .174). We identified reduced hospital stays (4.7 ± 1.3 vs 7.2±2.3 days; P &lt; .001) and lower hospital costs ($7771 vs 8539; P &lt; .001) in the ERAS CP group compared with the conventional CP group. Conclusions An ERAS CP can be safely and effectively adopted for patients with gastric cancer without increasing the complication rate and could shorten hospital stays. Trial Registration ClinicalTrials.gov (NCT01642953).</description><identifier>ISSN: 0022-4790</identifier><identifier>EISSN: 1096-9098</identifier><identifier>DOI: 10.1002/jso.25837</identifier><identifier>PMID: 31930513</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>clinical pathway ; clinical trial ; Clinical trials ; Critical Pathways ; Enhanced Recovery After Surgery ; Female ; gastrectomy ; Gastrectomy - adverse effects ; Gastrectomy - methods ; Gastrectomy - standards ; Gastric cancer ; Hospital costs ; Humans ; Male ; Middle Aged ; Minimally Invasive Surgical Procedures - adverse effects ; Minimally Invasive Surgical Procedures - methods ; Minimally Invasive Surgical Procedures - standards ; Prospective Studies ; Stomach Neoplasms - surgery</subject><ispartof>Journal of surgical oncology, 2020-03, Vol.121 (4), p.662-669</ispartof><rights>2020 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3537-5430714050c86c00ffb05fc18c62ca53578482289384ebd55607d496a705867b3</citedby><cites>FETCH-LOGICAL-c3537-5430714050c86c00ffb05fc18c62ca53578482289384ebd55607d496a705867b3</cites><orcidid>0000-0003-2254-6146 ; 0000-0001-5615-4162</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjso.25837$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjso.25837$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31930513$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Roh, Chul Kyu</creatorcontrib><creatorcontrib>Son, Sang‐Yong</creatorcontrib><creatorcontrib>Lee, Sook Young</creatorcontrib><creatorcontrib>Hur, Hoon</creatorcontrib><creatorcontrib>Han, Sang‐Uk</creatorcontrib><title>Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single‐center phase II clinical trial for safety and efficacy</title><title>Journal of surgical oncology</title><addtitle>J Surg Oncol</addtitle><description>Background We aimed to evaluate the safety and efficacy of a clinical pathway (CP) for enhanced recovery after surgery (ERAS) in gastric cancer patients, including early oral feeding and discharge on postoperative day 4. Methods We performed a prospective, single‐center, phase II clinical trial. Based on proposed indications for an ERAS CP in our retrospective study, we enrolled 133 patients younger than 65 years who were undergoing minimally invasive subtotal gastrectomy. The primary endpoint was the ERAS CP completion rate. Secondary endpoints included complication, mortality, hospital stay, and readmission. Results Among 133 patients, six patients were dropped out from this study. The ERAS CP completion rate (77.2%, 98 of 127) was comparable to the historical control group that completed a conventional CP (85.4%, P = .085). The postoperative complication incidence (13.4%, 15 of 127) was also similar to that of the conventional CP group (9.5%, P = .174). We identified reduced hospital stays (4.7 ± 1.3 vs 7.2±2.3 days; P &lt; .001) and lower hospital costs ($7771 vs 8539; P &lt; .001) in the ERAS CP group compared with the conventional CP group. Conclusions An ERAS CP can be safely and effectively adopted for patients with gastric cancer without increasing the complication rate and could shorten hospital stays. Trial Registration ClinicalTrials.gov (NCT01642953).</description><subject>clinical pathway</subject><subject>clinical trial</subject><subject>Clinical trials</subject><subject>Critical Pathways</subject><subject>Enhanced Recovery After Surgery</subject><subject>Female</subject><subject>gastrectomy</subject><subject>Gastrectomy - adverse effects</subject><subject>Gastrectomy - methods</subject><subject>Gastrectomy - standards</subject><subject>Gastric cancer</subject><subject>Hospital costs</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Minimally Invasive Surgical Procedures - adverse effects</subject><subject>Minimally Invasive Surgical Procedures - methods</subject><subject>Minimally Invasive Surgical Procedures - standards</subject><subject>Prospective Studies</subject><subject>Stomach Neoplasms - surgery</subject><issn>0022-4790</issn><issn>1096-9098</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc9u1DAQhy1ERZfCgRdAlri0h7ST-D-3akVhq0o9AOfI64x3s8omwU5a5cYj9NQH5Elw2JYDEhdb1nzzzcg_Qt7lcJ4DFBe72J0XQjP1gixyMDIzYPRLski1IuPKwDF5HeMOAIyR_BU5ZrlhIHK2II_Lpm5rZxva22F7byfqu0Cx3drWYUUDuu4Ow0StHzDQOIbN_JqZjY1DqB11Mxk-0kvahy726Ib6Dmms202Dv34-OGznzn5rI9LVirrneak5nbMpWo9DGtFWFL1PRTe9IUfeNhHfPt0n5PvVp2_LL9nN7efV8vImc0wwlQnOQOUcBDgtHYD3axDe5drJwlnBhNJcF4U2THNcV0JIUBU30ioQWqo1OyGnB2_a_ceIcSj3dXTYNLbFboxlwZgGmfNCJ_TDP-iuG0ObtkuUUFxwqXiizg6US58RA_qyD_XehqnMoZzDKlNY5Z-wEvv-yTiu91j9JZ_TScDFAbivG5z-byqvv94elL8BxWWfVw</recordid><startdate>20200301</startdate><enddate>20200301</enddate><creator>Roh, Chul Kyu</creator><creator>Son, Sang‐Yong</creator><creator>Lee, Sook Young</creator><creator>Hur, Hoon</creator><creator>Han, Sang‐Uk</creator><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-2254-6146</orcidid><orcidid>https://orcid.org/0000-0001-5615-4162</orcidid></search><sort><creationdate>20200301</creationdate><title>Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single‐center phase II clinical trial for safety and efficacy</title><author>Roh, Chul Kyu ; Son, Sang‐Yong ; Lee, Sook Young ; Hur, Hoon ; Han, Sang‐Uk</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3537-5430714050c86c00ffb05fc18c62ca53578482289384ebd55607d496a705867b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>clinical pathway</topic><topic>clinical trial</topic><topic>Clinical trials</topic><topic>Critical Pathways</topic><topic>Enhanced Recovery After Surgery</topic><topic>Female</topic><topic>gastrectomy</topic><topic>Gastrectomy - adverse effects</topic><topic>Gastrectomy - methods</topic><topic>Gastrectomy - standards</topic><topic>Gastric cancer</topic><topic>Hospital costs</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Minimally Invasive Surgical Procedures - adverse effects</topic><topic>Minimally Invasive Surgical Procedures - methods</topic><topic>Minimally Invasive Surgical Procedures - standards</topic><topic>Prospective Studies</topic><topic>Stomach Neoplasms - surgery</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Roh, Chul Kyu</creatorcontrib><creatorcontrib>Son, Sang‐Yong</creatorcontrib><creatorcontrib>Lee, Sook Young</creatorcontrib><creatorcontrib>Hur, Hoon</creatorcontrib><creatorcontrib>Han, Sang‐Uk</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of surgical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Roh, Chul Kyu</au><au>Son, Sang‐Yong</au><au>Lee, Sook Young</au><au>Hur, Hoon</au><au>Han, Sang‐Uk</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single‐center phase II clinical trial for safety and efficacy</atitle><jtitle>Journal of surgical oncology</jtitle><addtitle>J Surg Oncol</addtitle><date>2020-03-01</date><risdate>2020</risdate><volume>121</volume><issue>4</issue><spage>662</spage><epage>669</epage><pages>662-669</pages><issn>0022-4790</issn><eissn>1096-9098</eissn><abstract>Background We aimed to evaluate the safety and efficacy of a clinical pathway (CP) for enhanced recovery after surgery (ERAS) in gastric cancer patients, including early oral feeding and discharge on postoperative day 4. Methods We performed a prospective, single‐center, phase II clinical trial. Based on proposed indications for an ERAS CP in our retrospective study, we enrolled 133 patients younger than 65 years who were undergoing minimally invasive subtotal gastrectomy. The primary endpoint was the ERAS CP completion rate. Secondary endpoints included complication, mortality, hospital stay, and readmission. Results Among 133 patients, six patients were dropped out from this study. The ERAS CP completion rate (77.2%, 98 of 127) was comparable to the historical control group that completed a conventional CP (85.4%, P = .085). The postoperative complication incidence (13.4%, 15 of 127) was also similar to that of the conventional CP group (9.5%, P = .174). We identified reduced hospital stays (4.7 ± 1.3 vs 7.2±2.3 days; P &lt; .001) and lower hospital costs ($7771 vs 8539; P &lt; .001) in the ERAS CP group compared with the conventional CP group. Conclusions An ERAS CP can be safely and effectively adopted for patients with gastric cancer without increasing the complication rate and could shorten hospital stays. Trial Registration ClinicalTrials.gov (NCT01642953).</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>31930513</pmid><doi>10.1002/jso.25837</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-2254-6146</orcidid><orcidid>https://orcid.org/0000-0001-5615-4162</orcidid></addata></record>
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source MEDLINE; Wiley Online Library Journals Frontfile Complete
subjects clinical pathway
clinical trial
Clinical trials
Critical Pathways
Enhanced Recovery After Surgery
Female
gastrectomy
Gastrectomy - adverse effects
Gastrectomy - methods
Gastrectomy - standards
Gastric cancer
Hospital costs
Humans
Male
Middle Aged
Minimally Invasive Surgical Procedures - adverse effects
Minimally Invasive Surgical Procedures - methods
Minimally Invasive Surgical Procedures - standards
Prospective Studies
Stomach Neoplasms - surgery
title Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single‐center phase II clinical trial for safety and efficacy
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