Clinical trial NCT06984952: Effectiveness of ERAS on Postoperative Recovery After Minimally Invasive Gastrectomy
Official title: Effectiveness of Enhanced Recovery After Surgery (ERAS) on Postoperative Recovery After Minimally Invasive Gastrectomy: A Multi-center Open-labeled Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Enhanced Recovery After Surgery
Gastrectomy for Gastric Cancer
Keywords: enhanced recovery after surgery
stomach neoplasms
gastrectomy for gastric cancer
pain, postoperative
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Seoul National University Boramae Hospital
name: Severance Hospital
name: Chungnam National University Hospital
name: Keimyung University Dongsan Medical Center
name: National Cancer Center, Korea
name: The Catholic University of Korea
name: Ajou University School of Medicine
name: Pusan National University Hospital
First posted: 2025-05-22
Enrollment: 308
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized open-labeled, multicenter study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who fulfilled all of the predefined discharge criteria
timeFrame: At 9:00 AM on postoperative day
Secondary outcomes:
measure: Postoperative pain score
timeFrame: postoperative 2, 24, 48, and 72 hours
measure: Postoperative gastrointestinal dysfunction
timeFrame: postoperative 24, 48, and 72 hours
measure: Postoperative nausea and vomiting
timeFrame: From the end of surgery to 24, 48, and 72 hours postoperatively
measure: Quality of recovery assessed using the EQ-5D-5L questionnaire
timeFrame: postoperative 24, 48, and 72 hours
measure: Major postoperative complication
timeFrame: At 30 days postoperatively
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Dongsan Hospital, Keimyung University School of Medicine
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center,
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
Study officials:
affiliation: Seoul National University Hospital
name: Do Joong Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 May;25:e27. https://doi.org/10.5230/jgc.2025.25.e27
citation: 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.