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Effectiveness of Enhanced Recovery After Surgery (ERAS) on Postoperative Recovery After Minimally Invasive Gastrectomy: A Multi-center Open-labeled Randomized Controlled Study
This prospective, randomized, open-label, multicenter study is designed to evaluate the impact of an enhanced recovery after surgery (ERAS) protocol on the rate of meeting discharge criteria in patients undergoing minimally-invasive gastrectomy for gastric cancer. We hypothesize that implementation of our ERAS protocol will significantly increase the proportion of patients who meet standardized discharge criteria following minimally-invasive gastrectomy.
Adult patients undergoing elective minimally invasive gastrectomy were randomly allocated to receive either the ERAS protocol (n = 154) or the conventional protocol (n = 154). The conventional group received the current standard perioperative care at our institution, whereas the ERAS group received a newly developed ERAS protocol, which included preoperative carbohydrate loading, reduced perioperative fasting duration, and multimodal opioid-sparing analgesia. The primary outcome was the proportion of patients who met standardized discharge criteria at 9:00 AM on postoperative day 4. Secondary outcomes included the EQ-5D-5L index assessed at 24, 48, 72, and 96 hours postoperatively; pain intensity at rest and during coughing measured using an 11-point numeric rating scale at 2, 24, 48, and 72 hours postoperatively; gastrointestinal dysfunction assessed using the I-FEED score at 24, 48, and 72 hours postoperatively; the incidence of postoperative nausea and vomiting within 0-24, 24-48, and 48-72 hours after surgery; the incidence of major postoperative complications classified by the Clavien-Dindo grading system during hospitalization; and postoperative length of hospital stay.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
Pusan National University Hospital
Busan, South Korea
Dongsan Hospital, Keimyung University School of Medicine
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
National Cancer Center
Goyang, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
Seoul St. Mary's Hospital
Seoul, South Korea
Severance hospital
Seoul, South Korea
SMG-SNU Boramae Medical Center,
Seoul, South Korea
Ajou University School of Medicine
Suwon, South Korea
Start Date
June 13, 2025
Primary Completion Date
December 31, 2028
Completion Date
March 31, 2029
Last Updated
September 5, 2025
308
ESTIMATED participants
ERAS protocol
PROCEDURE
Lead Sponsor
Seoul National University Hospital
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06369194