Overview
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.
Description
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.
Eligibility
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