Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
ID06984952

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

Led by Seoul National University Hospital · Updated on 2025-09-05

308

Participants Needed

10

Research Sites

12 weeks

Total Duration

On this page

Sponsors

S

Seoul National University Hospital

Lead Sponsor

S

Seoul National University Bundang Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of an Enhanced Recovery After Surgery (ERAS) protocol on recovery following minimally invasive gastrectomy in adults with gastric cancer. This prospective, randomized, open-label, multicenter study compares the ERAS protocol to conventional perioperative care to see if more patients meet discharge criteria earlier after surgery. The study aims to improve post-surgery recovery and reduce hospital stays by using evidence-based practices. Participants are randomly assigned to either the ERAS group or the conventional care group. The ERAS protocol includes preoperative carbohydrate loading, shorter fasting periods, multimodal opioid-sparing pain relief, early removal of drains and intravenous lines, early mobilization, and prevention of nausea and vomiting. The conventional group receives the current standard care at the institution. Both groups undergo minimally invasive gastrectomy, either laparoscopic or robotic. During the study, patients are monitored for meeting discharge criteria at 9:00 AM on postoperative day 4. Researchers also assess pain levels, gastrointestinal function, nausea and vomiting, quality of recovery using the EQ-5D-5L questionnaire, and major postoperative complications up to 30 days after surgery. Patients provide feedback through questionnaires, and their health is closely followed to evaluate the benefits of the ERAS protocol compared to conventional care.

CONDITIONS

Brief Title

Effectiveness of ERAS on Postoperative Recovery After Minimally Invasive Gastrectomy

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 19 years or older scheduled for elective laparoscopic or robotic gastrectomy for gastric cancer
  • American Society of Anesthesiologists physical status classification I to III
  • Ability to provide written informed consent and complete patient-reported outcome measures
Not Eligible

You will not qualify if you...

  • Need for resection of organs other than the stomach during surgery (except gallbladder removal)
  • History of upper abdominal surgery (except gallbladder removal)
  • Known allergy to fentanyl, ropivacaine, acetaminophen, or non-steroidal anti-inflammatory drugs
  • Deemed unsuitable for study participation by investigators

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay until discharge, typically around 4 days post-surgery

Participants undergo minimally invasive gastrectomy followed by immediate postoperative care according to either the ERAS protocol or conventional care.

Daily hospital visits during postoperative stay

Post-operative Follow-up

Duration - Up to 30 days postoperatively

Participants are monitored for recovery outcomes including pain, gastrointestinal function, nausea and vomiting, quality of recovery, and complications up to 30 days after surgery.

Assessments at 2, 24, 48, 72, and 96 hours post-surgery and follow-up visits up to 30 days

Trial Site Locations

Total: 10 locations

1

Pusan National University Hospital

Busan, South Korea

Not Yet Recruiting

2

Dongsan Hospital, Keimyung University School of Medicine

Daegu, South Korea

Actively Recruiting

3

Chungnam National University Hospital

Daejeon, South Korea

Not Yet Recruiting

4

National Cancer Center

Goyang, South Korea

Not Yet Recruiting

5

Seoul National University Bundang Hospital

Seongnam, South Korea

Not Yet Recruiting

6

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

7

Seoul St. Mary's Hospital

Seoul, South Korea

Not Yet Recruiting

8

Severance hospital

Seoul, South Korea

Not Yet Recruiting

9

SMG-SNU Boramae Medical Center,

Seoul, South Korea

Not Yet Recruiting

10

Ajou University School of Medicine

Suwon, South Korea

Not Yet Recruiting

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Research Team

H

Hojin Lee, MD, PhD

D

Do Joong Park, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Survey of Perioperative Practices in Gastric Cancer Surgery for Establishing an Enhanced Recovery After Surgery Program Across 10 Tertiary Hospitals in South Korea.

Ho-Jin Lee, Jeesun Kim, Bon-Wook Koo...

https://pubmed.ncbi.nlm.nih.gov/40631472