Effectiveness of Enhanced Recovery After Surgery (ERAS) on Postoperative Recovery After Minimally Invasive Gastrectomy: A Multi-center Open-labeled Randomized Controlled Study
| Registry | NCT06984952 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 308 (Estimated) |
| Sponsor | Seoul National University Hospital (Other); collaborators: Seoul National University Bundang Hospital, Seoul National University Boramae Hospital, Severance Hospital, Chungnam National University Hospital, Keimyung University Dongsan Medical Center, National Cancer Center, Korea, The Catholic University of Korea, Ajou University School of Medicine, Pusan National University Hospital |
| Conditions | Enhanced Recovery After Surgery, Gastrectomy for Gastric Cancer |
| Interventions | ERAS protocol (Procedure) |
| Dates | start 2025-06-13, primary completion 2028-12-31 (estimated), completion 2029-03-31 (estimated), first posted 2025-05-22, last updated 2025-09-05 |
| Locations | 10 sites in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Enhanced Recovery After Surgery All trials for Gastrectomy for Gastric Cancer All trials of ERAS protocol
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ERAS group | Experimental | Procedure: ERAS protocol | Perioperative care for minimally-invasive gastrectomy is managed according to ERAS protocol. |
| Conventional group | No intervention | Perioperative care for minimally-invasive gastrectomy is managed according to our current perioperative practice |
Sex: All, ages: 19 Years to any
Inclusion Criteria: * 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 Exclusion Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Pusan National University Hospital | Busan | South Korea | Not yet recruiting |
| Dongsan Hospital, Keimyung University School of Medicine | Daegu | South Korea | Recruiting |
| Chungnam National University Hospital | Daejeon | South Korea | Not yet recruiting |
| National Cancer Center | Goyang | South Korea | Not yet recruiting |
| Seoul National University Bundang Hospital | Seongnam | South Korea | Not yet recruiting |
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
| Seoul St. Mary's Hospital | Seoul | South Korea | Not yet recruiting |
| Severance hospital | Seoul | South Korea | Not yet recruiting |
| SMG-SNU Boramae Medical Center, | Seoul | South Korea | Not yet recruiting |
| Ajou University School of Medicine | Suwon | South Korea | Not yet recruiting |