Effectiveness of Enhanced Recovery After Surgery (ERAS) on Postoperative Recovery After Laparoscopic Distal Gastrectomy: An Open-labeled Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change of the Quality of recovery-15 during the first 72 hours after surgery
研究概览
简要总结
This prospective, randomized, open-labeled study is designed to evaluate the impact of enhanced recovery after surgery (ERAS) protocol on postoperative quality of recovery in patients undergoing laparoscopic distal gastrectomy. We hypothesize that our ERAS protocol can significantly improve the postoperative quality of recovery in patients with laparoscopic distal gastrectomy.
详细描述
Adult patients undergoing elective laparoscopic distal gastrectomy are randomly allocated to receive the ERAS protocol (n=49) or conventional protocol (n=49). The conventional groups receive our current perioperative management. The ERAS groups receive our new ERAS protocol including preoperative carbohydrate loading, shortening of perioperative fasting time, and multimodal opioid-sparing analgesia. The primary outcome measure was the postoperative quality of recovery evaluated using the Korean version of Quality of recovery-15 at 24, 48, and 72 hours postoperatively. The secondary outcome measures were pain intensity at rest and during coughing evaluated using an 11-point numeric rating scale at 24, 48, and 72 hours postoperatively, gastrointestinal dysfunction evaluated using the I-FEED score at 24, 48, and 72 hours postoperatively, the occurrence of postoperative nausea and vomiting during the first postoperative 24 hours, postoperative 24 to 48 hour period, and postoperative 48 to 72 hour period, the occurrence of major postoperative complications according to the Clavien-Dindo classification during hospitalization, and 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo elective laparoscopic distal gastrectomy
- •American Society of Anesthesiologists (ASA)physical classification I-II
- •ECOG Performance Status Scale 0 or 1
- •Willingness and ability to sign an informed consent document
排除标准
- •Patients with chronic pain
- •Gastrectomy with combined resection of other organs
- •Patients with history of upper abdominal surgery
- •Allergies to anesthetic or analgesic medications (fentanyl, ropivacaine, acetaminophen, NSAIDs)
- •Medical or psychological disease that can affect the treatment response
研究组 & 干预措施
ERAS group
Perioperative care for laparoscopic distal gastrectomy is managed according to ERAS protocol.
干预措施: ERAS protocol (Procedure)
Conventional group
Perioperative care for laparoscopic distal gastrectomy is managed according to our current perioperative practice.
结局指标
主要结局
Change of the Quality of recovery-15 during the first 72 hours after surgery
时间窗: postoperative 24, 48, and 72 hours
Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"
次要结局
- Postoperative pain score(postoperative 24, 48, and 72 hours)
- Total fentanyl consumption(From the end of surgery to 24, 48, and 72 hours postoperatively)
- Postoperative nausea and vomiting(From the end of surgery to 24, 48, and 72 hours postoperatively)
- Postoperative gastrointestinal dysfunction(postoperative 24, 48, and 72 hours)
- Recovery time(Evaluate every hour starting from 9A on the postoperative day 3 up to discharge)
研究者
Hojin Lee, MD, PhD
Professor
Seoul National University Hospital