Effectiveness of ERAS on Postoperative Recovery After Minimally Invasive Gastrectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥19 years scheduled to undergo elective laparoscopic or robotic gastrectomy for gastric cancer
American Society of Anesthesiologists physical status classification I to III
Ability to provide written informed consent, demonstrate understanding of the study protocol, and complete patient-reported outcome measures appropriately
Disqualifiers
Requirement for resection of organs other than the stomach during surgery (except for cholecystectomy)
History of upper abdominal surgery (except for cholecystectomy)
Known hypersensitivity to fentanyl, ropivacaine, acetaminophen, or non-steroidal anti-inflammatory drugs
Determined by the investigator or study personnel to be otherwise unsuitable for participation in the study
Trial design
Design model
Parallel
Treatments tested in this trial
ERAS protocol
Procedure/SurgeryThe 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 \[https://doi.org/10.5230/jgc.2025.25.e27\].
Treatment groups
308 Participants
are divided into 2 treatment groupsGroup A: ERAS groupExperimental treatment 1 intervention
Group B: Conventional groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Proportion 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 daySecondary outcomes
1
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 hours2
Postoperative gastrointestinal dysfunction
I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction)
Time frame
postoperative 24, 48, and 72 hours3
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting (%)
Time frame
From the end of surgery to 24, 48, and 72 hours postoperatively4
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 hoursSponsors and contacts
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Seoul National University Hospital
Lead sponsor
Seoul National University Bundang Hospital
Collaborator
Seoul National University Boramae Hospital
Collaborator
Severance Hospital
Collaborator
Chungnam National University Hospital
Collaborator
Keimyung University Dongsan Medical Center
Collaborator
National Cancer Center, Korea
Collaborator
The Catholic University of Korea
Collaborator
Ajou University School of Medicine
Collaborator
Pusan National University Hospital
Collaborator
Source ClinicalTrials.gov