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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| Seoul National University Boramae Hospital | OTHER |
| Severance Hospital | OTHER |
| Chungnam National University Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERAS group | Experimental | Perioperative care for minimally-invasive gastrectomy is managed according to ERAS protocol. |
|
| Conventional group | No Intervention | Perioperative care for minimally-invasive gastrectomy is managed according to our current perioperative practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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\]. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who fulfilled all of the predefined discharge criteria | Discharge criteria were defined as meeting all of the following conditions:
| At 9:00 AM on postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score | 11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable" | postoperative 2, 24, 48, and 72 hours |
| Postoperative gastrointestinal dysfunction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hojin Lee, MD, PhD | Contact | 82-2-2072-2467 | hjpainfree@snu.ac.kr | |
| Do Joong Park, MD, PhD | Contact | 82-2-2072-2318 | djparkmd@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Do Joong Park, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Not yet recruiting | Busan | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40631472 | Result | 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. | |
| 40072360 |
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| OTHER |
| Keimyung University Dongsan Medical Center | OTHER |
| National Cancer Center, Korea | OTHER_GOV |
| The Catholic University of Korea | OTHER |
| Ajou University School of Medicine | OTHER |
| Pusan National University Hospital | OTHER |
A prospective randomized open-labeled, multicenter study
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|
I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction)
| postoperative 24, 48, and 72 hours |
| Postoperative nausea and vomiting | Incidence of 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 | 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) | postoperative 24, 48, and 72 hours |
| 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. | At 30 days postoperatively |
| Dongsan Hospital, Keimyung University School of Medicine | Recruiting | Daegu | South Korea |
|
| Chungnam National University Hospital | Not yet recruiting | Daejeon | South Korea |
|
| National Cancer Center | Not yet recruiting | Goyang | South Korea |
|
| Seoul National University Bundang Hospital | Not yet recruiting | Seongnam | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| Seoul St. Mary's Hospital | Not yet recruiting | Seoul | South Korea |
|
| Severance hospital | Not yet recruiting | Seoul | South Korea |
|
| SMG-SNU Boramae Medical Center, | Not yet recruiting | Seoul | South Korea |
|
| Ajou University School of Medicine | Not yet recruiting | Suwon | South Korea |
|
| Result |
| 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. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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