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NCT Number: NCT06984952

Effectiveness of ERAS on Postoperative Recovery After Minimally Invasive Gastrectomy

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Hospital, Busan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERAS protocol

Procedure

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].

Primary outcomes

  1. 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

Secondary outcomes

  1. 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"

  2. Postoperative gastrointestinal dysfunction

    Time frame: postoperative 24, 48, and 72 hours

    I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction)

  3. Postoperative nausea and vomiting

    Time frame: From the end of surgery to 24, 48, and 72 hours postoperatively

    Incidence of postoperative nausea and vomiting (%)

  4. 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)

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Do Joong Park, MD, PhD

CONTACT

[email protected]

Hojin Lee, MD, PhD

CONTACT

[email protected]

82-2-2072-2467

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
May 22, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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