Effectiveness of ERAS on Postoperative Recovery After Minimally Invasive Gastrectomy

Not Applicable

Not yet recruiting

• Conditions: Gastrectomy for Gastric Cancer; Enhanced Recovery After Surgery

• Registration Number: NCT06984952
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Study First Posted: 2025-05-22
• Study Start: 2025-05-26
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31
• Primary Completion: 2028-12-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 308

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients who fulfilled all of the predefined discharge criteria	At 9:00 AM on postoperative day	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

Secondary Outcome Measures

Name	Time	Method
Postoperative pain score	postoperative 2, 24, 48, and 72 hours	11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"
Quality of recovery assessed using the EQ-5D-5L questionnaire	postoperative 24, 48, and 72 hours	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)
Postoperative gastrointestinal dysfunction	postoperative 24, 48, and 72 hours	I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction)
Postoperative nausea and vomiting	From the end of surgery to 24, 48, and 72 hours postoperatively	Incidence of postoperative nausea and vomiting (%)
Major postoperative complication	At 30 days postoperatively	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.

Trial Locations

Locations (10)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Dongsan Hospital, Keimyung University School of Medicine; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

National Cancer Center; 🇰🇷 Goyang, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance hospital; 🇰🇷 Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center,; 🇰🇷 Seoul, Korea, Republic of

Ajou University School of Medicine; 🇰🇷 Suwon, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of