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 |
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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 |
doi_str_mv | 10.1002/jso.25837 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2338061428</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2357454674</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3537-5430714050c86c00ffb05fc18c62ca53578482289384ebd55607d496a705867b3</originalsourceid><addsrcrecordid>eNp1kc9u1DAQhy1ERZfCgRdAlri0h7ST-D-3akVhq0o9AOfI64x3s8omwU5a5cYj9NQH5Elw2JYDEhdb1nzzzcg_Qt7lcJ4DFBe72J0XQjP1gixyMDIzYPRLski1IuPKwDF5HeMOAIyR_BU5ZrlhIHK2II_Lpm5rZxva22F7byfqu0Cx3drWYUUDuu4Ow0StHzDQOIbN_JqZjY1DqB11Mxk-0kvahy726Ib6Dmms202Dv34-OGznzn5rI9LVirrneak5nbMpWo9DGtFWFL1PRTe9IUfeNhHfPt0n5PvVp2_LL9nN7efV8vImc0wwlQnOQOUcBDgtHYD3axDe5drJwlnBhNJcF4U2THNcV0JIUBU30ioQWqo1OyGnB2_a_ceIcSj3dXTYNLbFboxlwZgGmfNCJ_TDP-iuG0ObtkuUUFxwqXiizg6US58RA_qyD_XehqnMoZzDKlNY5Z-wEvv-yTiu91j9JZ_TScDFAbivG5z-byqvv94elL8BxWWfVw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2357454674</pqid></control><display><type>article</type><title>Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single‐center phase II clinical trial for safety and efficacy</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Roh, Chul Kyu ; Son, Sang‐Yong ; Lee, Sook Young ; Hur, Hoon ; Han, Sang‐Uk</creator><creatorcontrib>Roh, Chul Kyu ; Son, Sang‐Yong ; Lee, Sook Young ; Hur, Hoon ; Han, Sang‐Uk</creatorcontrib><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 < .001) and lower hospital costs ($7771 vs 8539; P < .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 < .001) and lower hospital costs ($7771 vs 8539; P < .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 & 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 < .001) and lower hospital costs ($7771 vs 8539; P < .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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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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