Effectiveness of ERAS on Postoperative Recovery After Minimally Invasive Gastrectomy

September 4, 2025 updated by: Hojin Lee, MD, PhD, Seoul National University Hospital

Effectiveness of Enhanced Recovery After Surgery (ERAS) on Postoperative Recovery After Minimally Invasive Gastrectomy: A Multi-center Open-labeled Randomized Controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

308

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
      • Busan, South Korea
        • Not yet recruiting
        • Pusan National University Hospital
        • Contact:
      • Daegu, South Korea
        • Recruiting
        • Dongsan Hospital, Keimyung University School of Medicine
        • Contact:
      • Daejeon, South Korea
        • Not yet recruiting
        • Chungnam National University Hospital
        • Contact:
      • Goyang, South Korea
        • Not yet recruiting
        • National Cancer Center
        • Contact:
      • Seongnam, South Korea
        • Not yet recruiting
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Contact:
          • Do Joong Park, MD, PhD
          • Phone Number: 82-2-2072-2318 82-2-2072-2318
          • Email: djparkmd@snu.ac.kr
        • Principal Investigator:
          • Do Joong Park Park, MD, PhD
      • Seoul, South Korea
        • Not yet recruiting
        • Seoul St. Mary's Hospital
        • Contact:
      • Seoul, South Korea
        • Not yet recruiting
        • Severance Hospital
        • Contact:
          • Hyoung-Il Kim, MD, PhD
          • Phone Number: +82-2-2228-1004
          • Email: cairus@yuhs.ac
      • Seoul, South Korea
        • Not yet recruiting
        • SMG-SNU Boramae Medical Center,
        • Contact:
      • Suwon, South Korea
        • Not yet recruiting
        • Ajou University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERAS group
Perioperative care for minimally-invasive gastrectomy is managed according to ERAS protocol.
Procedure: ERAS protocol
The 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].
No Intervention: Conventional group
Perioperative care for minimally-invasive gastrectomy is managed according to our current perioperative practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who fulfilled all of the predefined discharge criteria
Time Frame: 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
At 9:00 AM on postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative gastrointestinal dysfunction
Time Frame: postoperative 24, 48, and 72 hours
I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction)
postoperative 24, 48, and 72 hours
Postoperative nausea and vomiting
Time Frame: From the end of surgery to 24, 48, and 72 hours postoperatively
Incidence of postoperative nausea and vomiting (%)
From the end of surgery to 24, 48, and 72 hours postoperatively
Postoperative pain score
Time Frame: 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"
postoperative 2, 24, 48, and 72 hours
Quality of recovery assessed using the EQ-5D-5L questionnaire
Time Frame: 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 24, 48, and 72 hours
Major postoperative complication
Time Frame: 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.
At 30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

National Cancer Center, Korea
Pusan National University Hospital
Seoul National University Bundang Hospital
Ajou University School of Medicine
Seoul National University Boramae Hospital
The Catholic University of Korea
Severance Hospital
Keimyung University Dongsan Medical Center
Chungnam National University Hospital

Investigators

  • Principal Investigator: Do Joong Park, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

May 14, 2025

First Submitted That Met QC Criteria

May 14, 2025

First Posted (Actual)

May 22, 2025

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2501-115-1609

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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