Effectiveness of ERAS on Postoperative Recovery After Minimally Invasive Gastrectomy

Seoul National University

Status

Enrolling

Conditions

Gastrectomy for Gastric Cancer

Enhanced Recovery After Surgery

Treatments

Procedure: ERAS protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT06984952

2501-115-1609

Details and patient eligibility

About

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.

Full 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.

Enrollment

308 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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