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AzTrials

Enhanced Recovery After SurgeryNCT06984952

Effectiveness of ERAS on Postoperative Recovery After Minimally Invasive Gastrectomy

A study testing ERAS protocol in people with Enhanced Recovery After Surgery and Gastrectomy for Gastric Cancer, run by Seoul National University Hospital at 10 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
ERAS protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
10 sitesSouth Korea
Study dates
13 Jun 2025to 31 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hojin Lee, MD, PhD contact

82-2-2072-2467

hjpainfree@snu.ac.kr

Do Joong Park, MD, PhD contact

djparkmd@snu.ac.kr

10 sites in 1 country

South Korea10 sites, 10 recruiting

  • Pusan National University Hospital

    Busan

    Chang In Choi, MD, PhD, 82-51-240-7000, getz0621@gmail.com

    Not yet recruiting

  • Dongsan Hospital, Keimyung University School of Medicine

    Daegu

    Seung Wan Ryu, MD, PhD, 82-1577-6622, koreagsman@gmail.com

    Recruiting

  • Chungnam National University Hospital

    Daejeon

    Sang-Il Lee, MD, PhD, 82-1599-7123, mr231@cnu.ac.kr

    Not yet recruiting

  • National Cancer Center

    Goyang

    Hong Man Yoon Yoon, MD, PhD, +82-31-920-1931, red10000@ncc.re.kr

    Not yet recruiting

  • Seoul National University Bundang Hospital

    Seongnam

    Yun-Suhk Suh Suh, MD, PhD, 82-1588-3369, ysksuh@snu.ac.kr

    Not yet recruiting

  • Seoul National University Hospital

    Seoul

    Hojin Lee, MD, PhD, 82-2-2072-0039 ext. 82-2-2072-0039, hjpainfree@snu.ac.kr

    Do Joong Park, MD, PhD, 82-2-2072-2318 ext. 82-2-2072-2318, djparkmd@snu.ac.kr

    Recruiting

  • Seoul St. Mary's Hospital

    Seoul

    Han Hong Lee, MD, PhD, +82-2-2258-1511, painkiller9@catholic.ac.kr

    Not yet recruiting

  • Severance hospital

    Seoul

    Hyoung-Il Kim, MD, PhD, +82-2-2228-1004, cairus@yuhs.ac

    Not yet recruiting

  • SMG-SNU Boramae Medical Center,

    Seoul

    Dong-Seok Han, MD, PhD, 82-1577-0075, handongseok@gmail.com

    Not yet recruiting

  • Ajou University School of Medicine

    Suwon

    Hoon Hur, MD, PhD, 82-31-219-4311, hhcmc75@ajou.ac.kr

    Not yet recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
ERAS protocol
Keywords
enhanced recovery after surgery, stomach neoplasms, gastrectomy for gastric cancer, pain, postoperative
Medical subject headings
Stomach Neoplasms, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERAS protocolProcedure or surgery

    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].

Study groups in NCT06984952
Study groupRoleWhat they receive
ERAS groupExperimentalPerioperative care for minimally-invasive gastrectomy is managed according to ERAS protocol.
Receives: Procedure: ERAS protocol
Conventional groupNo interventionPerioperative care for minimally-invasive gastrectomy is managed according to our current perioperative practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients who fulfilled all of the predefined discharge criteria

    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

    Measured: At 9:00 AM on postoperative day

Secondary outcomes (5)

  1. Postoperative pain score

    11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"

    Measured: postoperative 2, 24, 48, and 72 hours

  2. Postoperative gastrointestinal dysfunction

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

    Measured: postoperative 24, 48, and 72 hours

  3. Postoperative nausea and vomiting

    Incidence of postoperative nausea and vomiting (%)

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

  4. Quality of recovery assessed using the EQ-5D-5L questionnaire

    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)

    Measured: postoperative 24, 48, and 72 hours

  5. Major postoperative complication

    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.

    Measured: At 30 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2025
  2. Study start13 Jun 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective randomized open-labeled, multicenter study
Masking
None (open label)
Enrolment
308 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06984952
Sponsor's protocol ID
2501-115-1609
Status last verified
Sep 2025
First submitted
14 May 2025
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lee HJ, Kim J, Koo BW, Suh YS, Lee JM, Han DS, Hong SH, Lee HH, Yoo YC, Kim HI, Rho JY, Yoon HM, Kim HY, Hur H, Kim HJ, Choi CI, Hong B, Lee SI, Park K, Ryu SW, Park DJ. Survey of Perioperative Practices in Gastric Cancer Surgery for Establishing an Enhanced Recovery After Surgery Program Across 10 Tertiary Hospitals in South Korea. J Gastric Cancer. 2025 Jul;25(3):424-436. doi: 10.5230/jgc.2025.25.e27.

    PubMed 40631472

  • Lee HJ, Kim J, Yoon SH, Kong SH, Kim WH, Park DJ, Lee HJ, Yang HK. Effectiveness of ERAS program on postoperative recovery after gastric cancer surgery: a randomized clinical trial. Int J Surg. 2025 May 1;111(5):3306-3313. doi: 10.1097/JS9.0000000000002328.

    PubMed 40072360

Questions about this trial

What is this clinical trial studying?

A study testing ERAS protocol in people with Enhanced Recovery After Surgery and Gastrectomy for Gastric Cancer, run by Seoul National University Hospital at 10 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hojin Lee, MD, PhD (82-2-2072-2467, hjpainfree@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who fulfilled all of the predefined discharge criteria (time frame: At 9:00 AM on postoperative day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06984952, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.

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