Enhanced Recovery After Surgery, Gastrectomy for Gastric Cancer
Conditions
Keywords
enhanced recovery after surgery, stomach neoplasms, gastrectomy for gastric cancer, pain, postoperative
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.
Interventions
PROCEDUREERAS protocol
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 \[https://doi.org/10.5230/jgc.2025.25.e27\].
Sponsors
Seoul National University Bundang Hospital
Seoul National University Boramae Hospital
Severance Hospital
Chungnam National University Hospital
Keimyung University Dongsan Medical Center
National Cancer Center, Korea
The Catholic University of Korea
Ajou University School of Medicine
Pusan National University Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective randomized open-labeled, multicenter study
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who fulfilled all of the predefined discharge criteria | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score | 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 |
| Postoperative gastrointestinal dysfunction | postoperative 24, 48, and 72 hours | I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction) |
| Postoperative nausea and vomiting | From the end of surgery to 24, 48, and 72 hours postoperatively | Incidence of postoperative nausea and vomiting (%) |
| Quality of recovery assessed using the EQ-5D-5L questionnaire | 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) |
| Major postoperative complication | 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. |
Countries
South Korea
Contacts
Primary ContactHojin Lee, MD, PhD
Backup ContactDo Joong Park, MD, PhD
Outcome results
None listed