Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study))
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Recovering Rate
研究概览
简要总结
Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.
详细描述
There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.
However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy.
The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgery
- •American Society of Anesthesiologists (ASA) scores < 3
- •20 < Age < 80
- •Gastric cancer, adenocarcinoma, possible to perform laparoscopic distal gastrectomy
- •Informed consent
- •No other treatment (Radiation, Chemotherapy or Immunotherapy) on this gastric cancer or other type of cancer.
- •No systemic inflammatory disease
排除标准
- •Emergency operation
研究组 & 干预措施
ERAS perioperative cares
Patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.
干预措施: ERAS perioperative cares (Procedure)
Conventional perioperative cares
Patents will be managed by our hospital's critical pathways.
干预措施: Conventional perioperative cares (Procedure)
结局指标
主要结局
Recovering Rate
时间窗: 4 days after surgery
1. Tolerance of diet for 24 hours A. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting 2. Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA) 3. Safe ambulation (ambulation of 600m without assistance) 4. Afebrile status without major complications (fever defined as body temperature greater than 37.5) * Above total 4 criteria should be satisfied for the evaluation of complete recovery.
次要结局
- Postoperative length of hospital stay(up to 4 weeks after surgery)
- Time to tolerance of a full diet(up to 1 month after surgery)
- Complications during the admissionTime to first bowel motion(up to 30 days after surgery)
- Quality of life(up to 1 month after surgery)
- Readmission rate(up to 30 days after surgery)
- Time to first bowel motion Time to first bowel motion(up to 7 days after surgery)
- Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days(up to 3 days after surgery)
研究者
Hyung-Ho Kim
Professor
Seoul National University Bundang Hospital