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Clinical Trial NCT06984952 for Enhanced Recovery After Surgery, Gastrectomy for Gastric Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Seoul National University HospitalEffectiveness of ERAS on Postoperative Recovery After Minimally Invasive Gastrectomy 308 Randomized Open-Label
Clinical Trial NCT06984952 is an interventional study for Enhanced Recovery After Surgery, Gastrectomy for Gastric Cancer that is recruiting. It started on 13 June 2025 with plans to enroll 308 participants. Led by Seoul National University Hospital, it is expected to complete by 31 March 2029. The latest data from ClinicalTrials.gov was last updated on 5 September 2025.
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 fol...Show More
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 duratio...Show More
Official Title
Effectiveness of Enhanced Recovery After Surgery (ERAS) on Postoperative Recovery After Minimally Invasive Gastrectomy: A Multi-center Open-labeled Randomized Controlled Study
Conditions
Enhanced Recovery After SurgeryGastrectomy for Gastric CancerPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 2501-115-1609
NCT ID Number
Start Date (Actual)
2025-06-13
Last Update Posted
2025-09-05
Completion Date (Estimated)
2029-03-31
Enrollment (Estimated)
308
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
enhanced recovery after surgery
stomach neoplasms
gastrectomy for gastric cancer
pain, postoperative
stomach neoplasms
gastrectomy for gastric cancer
pain, postoperative
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalERAS group Perioperative care for minimally-invasive gastrectomy is managed according to ERAS protocol. | ERAS 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. T...Show More |
No InterventionConventional group Perioperative care for minimally-invasive gastrectomy is managed according to our current perioperative practice | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | 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:
* 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 |
| Outcome Measure | 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 | 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
19 Years
Eligible Sexes
All
- 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
- 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
Seoul National University Hospital377 active studies to exploreStudy Responsible Party
Hojin Lee, MD, PhD, Principal Investigator, Professor, Seoul National University Hospital
Study Central Contact
Contact: Hojin Lee, MD, PhD, 82-2-2072-2467, [email protected]
Contact: Do Joong Park, MD, PhD, [email protected]
10 Study Locations in 1 Countries
Pusan National University Hospital, Busan, South Korea
Chang In Choi, MD, PhD, Contact, 82-51-240-7000, [email protected]
Not yet recruiting
Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea
Seung Wan Ryu, MD, PhD, Contact, 82-1577-6622, [email protected]
Recruiting
Chungnam National University Hospital, Daejeon, South Korea
Sang-Il Lee, MD, PhD, Contact, 82-1599-7123, [email protected]
Not yet recruiting
National Cancer Center, Goyang, South Korea
Hong Man Yoon Yoon, MD, PhD, Contact, +82-31-920-1931, [email protected]
Not yet recruiting
Seoul National University Bundang Hospital, Seongnam, South Korea
Yun-Suhk Suh Suh, MD, PhD, Contact, 82-1588-3369, [email protected]
Not yet recruiting
Seoul National University Hospital, Seoul, South Korea
Hojin Lee, MD, PhD, Contact, 82-2-2072-0039, [email protected]
Do Joong Park, MD, PhD, Contact, 82-2-2072-2318, [email protected]
Do Joong Park Park, MD, PhD, Principal Investigator
Recruiting
Seoul St. Mary's Hospital, Seoul, South Korea
Han Hong Lee, MD, PhD, Contact, +82-2-2258-1511, [email protected]
Not yet recruiting
Severance hospital, Seoul, South Korea
Hyoung-Il Kim, MD, PhD, Contact, +82-2-2228-1004, [email protected]
Not yet recruiting
SMG-SNU Boramae Medical Center,, Seoul, South Korea
Dong-Seok Han, MD, PhD, Contact, 82-1577-0075, [email protected]
Not yet recruiting
Ajou University School of Medicine, Suwon, South Korea
Hoon Hur, MD, PhD, Contact, 82-31-219-4311, [email protected]
Not yet recruiting