Effectiveness of Enhanced Recovery After Surgery (ERAS) on Postoperative Recovery After Minimally Invasive Gastrectomy: A Multi-center Open-labeled Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 308
- 试验地点
- 10
- 主要终点
- Proportion of patients who fulfilled all of the predefined discharge criteria
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ERAS group
Perioperative care for minimally-invasive gastrectomy is managed according to ERAS protocol.
干预措施: ERAS protocol (Procedure)
Conventional group
Perioperative care for minimally-invasive gastrectomy is managed according to our current perioperative practice
结局指标
主要结局
Proportion of patients who fulfilled all of the predefined discharge criteria
时间窗: 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
次要结局
- Postoperative pain score(postoperative 2, 24, 48, and 72 hours)
- Quality of recovery assessed using the EQ-5D-5L questionnaire(postoperative 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)
- Major postoperative complication(At 30 days postoperatively)
研究者
Hojin Lee, MD, PhD
Professor
Seoul National University Hospital