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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
308
The ERAS protocol includes pre-admission patient education through audiovisual materials; reduction of perioperative fasting duration with preoperative carbohydrate loading and early postoperative oral intake; multimodal prophylaxis for postoperative nausea and vomiting; early removal of surgical drains and intravenous lines; early mobilization; and multimodal analgesia aimed at minimizing postoperative opioid use. The detailed protocol used in this study has been published previously \[https://doi.org/10.5230/jgc.2025.25.e27\].
Pusan National University Hospital
Busan, South Korea
NOT_YET_RECRUITINGDongsan Hospital, Keimyung University School of Medicine
Daegu, South Korea
RECRUITINGChungnam National University Hospital
Daejeon, South Korea
NOT_YET_RECRUITINGNational Cancer Center
Goyang, South Korea
NOT_YET_RECRUITINGSeoul National University Bundang Hospital
Seongnam, South Korea
NOT_YET_RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGSeoul St. Mary's Hospital
Seoul, South Korea
NOT_YET_RECRUITINGSeverance hospital
Seoul, South Korea
NOT_YET_RECRUITINGSMG-SNU Boramae Medical Center,
Seoul, South Korea
NOT_YET_RECRUITINGAjou University School of Medicine
Suwon, South Korea
NOT_YET_RECRUITINGProportion of patients who fulfilled all of the predefined discharge criteria
Discharge criteria were defined as meeting all of the following conditions: * Tolerance of a soft blended diet (SBD) for at least 24 hours * Unaided ambulation of at least 600 meters * Adequate pain control, defined as a numeric rating scale (NRS) score of ≤ 3, achieved with oral non-opioid analgesics * Absence of abnormal physical examination findings or laboratory test results
Time frame: At 9:00 AM on postoperative day
Postoperative pain score
11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"
Time frame: postoperative 2, 24, 48, and 72 hours
Postoperative gastrointestinal dysfunction
I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction)
Time frame: postoperative 24, 48, and 72 hours
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting (%)
Time frame: From the end of surgery to 24, 48, and 72 hours postoperatively
Quality of recovery assessed using the EQ-5D-5L questionnaire
EQ-5D-5L index scores are calculated from the EQ-5D-5L questionnaire using the Korean value set validated for the Korean population. (range: 0 to 1.000, with higher scores indicating better recovery) (Kim SH, Ahn J, Ock M, et al. The EQ-5D-5L valuation study in Korea. Qual Life Res. 2016; 25: 1845-1852)
Time frame: postoperative 24, 48, and 72 hours
Major postoperative complication
Major postoperative complications are defined as events classified as Clavien-Dindo grade IIIa or higher and are assessed based on their incidence within 30 days after surgery.
Time frame: At 30 days postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.