A Randomized Controlled Trial of Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Recovering Rate
研究概览
简要总结
The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .
详细描述
The ERAS programs has been proved to be a useful solutions 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.
But few studies reported about the ERAS programs in the laparoscopic hepatectomy.
The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If patients were diagnosed with tumors
- •Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ
- •The tumor location and size do not affect the dissection of hepatic hilar region
- •Tumor size less than 10cm
- •Without portal vein tumor thrombus
- •Without intrahepatic or distant metastasis
- •Partial resection or half liver resection
- •Willingness to participate in the study
- •Able to understand the nature of the study and what will be required of them
- •Body mass index of between 18 and 35
- •Child-Pugh classification of A to B
- •American Society of Anesthesiologists (ASA) grading of I to III
排除标准
- •Pregnant or lactating women
- •Unwillingness to participate
- •Inability to give written informed consent
- •Child-Pugh classification of C
- •ASA grading of IV to V
- •Tumor invasion of the inferior vena cava or confluence part of hepatic vein
- •Decompensated liver cirrhosis
结局指标
主要结局
Recovering Rate
时间窗: 6 days after surgery
1. No major complication 2. Tolerance of semiliquid diet 3. Normal activity 4. Good pain control with analgesic-free or oral analgesics.
post-operative hospital stay
时间窗: up to 4 weeks after surgery
participants will be followed for the duration of hospital stay, an expected average of 6 days
次要结局
- cost of hospitalization(up to 1 month after surgery)
- associated cytokines in peripheral blood (IL-6, IL-10 and TNF-α)(before the operation, on postoperation 1 day, postoperation 2 day, postoperation 4 day)
- Estimated blood loss(the day of surgery)
- Time to functional recovery (days from operation to functional recovery)(up to 4 weeks after surgery)
- Quality of life(up to 1 month after surgery)
- Visual Analog Score for pain(up to 5 days after surgery)
- liver function(up to 1 month after surgery)
- operation time(the day of surgery)
研究者
Xiujun Cai
President
Sir Run Run Shaw Hospital