Effectiveness of ERAS on Postoperative Recovery After Minimally Invasive Gastrectomy

Last updated: September 4, 2025
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Gastric Cancer

Stomach Cancer

Treatment

ERAS protocol

Clinical Study ID

NCT06984952
2501-115-1609
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults aged ≥19 years scheduled to undergo elective laparoscopic or roboticgastrectomy for gastric cancer

  • American Society of Anesthesiologists physical status classification I to III

  • Ability to provide written informed consent, demonstrate understanding of the studyprotocol, and complete patient-reported outcome measures appropriately

Exclusion

Exclusion Criteria:

  • Requirement for resection of organs other than the stomach during surgery (exceptfor cholecystectomy)

  • History of upper abdominal surgery (except for cholecystectomy)

  • Known hypersensitivity to fentanyl, ropivacaine, acetaminophen, or non-steroidalanti-inflammatory drugs

  • Determined by the investigator or study personnel to be otherwise unsuitable forparticipation in the study

Study Design

Total Participants: 308
Treatment Group(s): 1
Primary Treatment: ERAS protocol
Phase:
Study Start date:
June 13, 2025
Estimated Completion Date:
March 31, 2029

Study 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.

Connect with a study center

  • Pusan National University Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Dongsan Hospital, Keimyung University School of Medicine

    Daegu,
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejeon,
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang,
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam,
    Korea, Republic of

    Site Not Available

  • SMG-SNU Boramae Medical Center,

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou University School of Medicine

    Suwon,
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Busan 1838524,
    South Korea

    Site Not Available

  • Dongsan Hospital, Keimyung University School of Medicine

    Daegu 1835329,
    South Korea

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon 1835235,
    South Korea

    Site Not Available

  • National Cancer Center

    Goyang 10913391,
    South Korea

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam 6876792,
    South Korea

    Site Not Available

  • SMG-SNU Boramae Medical Center,

    Seoul 1835848,
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848,
    South Korea

    Active - Recruiting

  • Seoul St. Mary's Hospital

    Seoul 1835848,
    South Korea

    Site Not Available

  • Severance hospital

    Seoul 1835848,
    South Korea

    Site Not Available

  • Ajou University School of Medicine

    Suwon 1835553,
    South Korea

    Site Not Available

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