Effectiveness of ERAS on Postoperative Recovery After Minimally Invasive Gastrectomy

NCT06984952 | Recruiting DMC

• 1 other identifier: 2501-115-1609
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Enhanced Recovery After Surgery; Gastrectomy for Gastric Cancer

Keywords

enhanced recovery after surgery; stomach neoplasms; gastrectomy for gastric cancer; pain, postoperative

Outcome Measures

Primary Outcomes (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

  At 9:00 AM on postoperative day

Secondary Outcomes (5)

• Postoperative pain score

  postoperative 2, 24, 48, and 72 hours

• Postoperative gastrointestinal dysfunction

  postoperative 24, 48, and 72 hours

• Postoperative nausea and vomiting

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

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

  postoperative 24, 48, and 72 hours

• Major postoperative complication

  At 30 days postoperatively

Study Arms (2)

ERAS group

EXPERIMENTAL

Perioperative care for minimally-invasive gastrectomy is managed according to ERAS protocol.

Procedure: ERAS protocol

Conventional group

NO INTERVENTION

Perioperative care for minimally-invasive gastrectomy is managed according to our current perioperative practice

Interventions

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 \[https://doi.org/10.5230/jgc.2025.25.e27\].

ERAS group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (10)

Pusan National University Hospital

Busan, South Korea

NOT YET RECRUITING

Dongsan Hospital, Keimyung University School of Medicine

Daegu, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

NOT YET RECRUITING

National Cancer Center

Goyang, South Korea

NOT YET RECRUITING

Seoul National University Bundang Hospital

Seongnam, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Seoul St. Mary's Hospital

Seoul, South Korea

NOT YET RECRUITING

Severance hospital

Seoul, South Korea

NOT YET RECRUITING

SMG-SNU Boramae Medical Center,

Seoul, South Korea

NOT YET RECRUITING

Ajou University School of Medicine

Suwon, South Korea

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 40631472 BACKGROUND

• 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.

  PMID: 40072360 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Do Joong Park, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hojin Lee, MD, PhD

CONTACT

82-2-2072-2467; hjpainfree@snu.ac.kr

Do Joong Park, MD, PhD

CONTACT

djparkmd@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective randomized open-labeled, multicenter study

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: June 13, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

KR (10)