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Clinical pathway for enhanced recovery after surgery for gastric cancer: A prospective single‐center phase II clinical trial for safety and efficacy
Author(s) -
Roh Chul Kyu,
Son SangYong,
Lee Sook Young,
Hur Hoon,
Han SangUk
Publication year - 2020
Publication title -
journal of surgical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.201
H-Index - 111
eISSN - 1096-9098
pISSN - 0022-4790
DOI - 10.1002/jso.25837
Subject(s) - medicine , clinical endpoint , surgery , clinical trial , single center , complication , gastrectomy , incidence (geometry) , prospective cohort study , cancer , cancer surgery , retrospective cohort study , randomized controlled trial , physics , optics
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).