Randomized Clinical Trial of Open Versus Laparoscopic Left Hepatic Sectionectomy in Treatment of Hepatolithiasis Within an Enhanced Recovery After Surgery Programme
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Hospital duration after operation (days)
研究概览
简要总结
Laparoscopic left sectionectomy has been associated with shorter hospital stay and reduced overall morbidity compared with open left sectionectomy. Strong evidence has not, however, been provided.
详细描述
The application of laparoscopic technology to liver surgery has been developing rapidly, yet very few studies have been conducted to compare the outcomes between open and laparoscopic liver resections. So little is known about their advantages and disadvantages. The aim of this prospective randomized study is to compare the outcomes between laparoscopic and open liver resection in treatment of hepatolithiasis within the left lobes within an enhanced recovery after surgery programme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suitable for undergoing both laparoscopic left sectionectomy as well as open left sectionectomy of the liver
- •Able to understand the nature of the study and what will be required of them
- •Men and non-pregnant,non-lactating women between age 18-80
- •BMI between 18-35
- •Patients with ASA I-II-III
排除标准
- •Inability to give written informed consent
- •Patients undergoing liver resection other than left lateral hepatic sectionectomy
- •Patients with ASA IV-V Underlying liver disease
结局指标
主要结局
Hospital duration after operation (days)
时间窗: up to 30 days after liver resection
the length of hospital stay
次要结局
- Blood transfusion (times and units)(intraoperative)
- Readmission percentage(up to 30 days after liver resection)
- Total morbidity(up to 1 year after liver resection)
- Mortality rates(up to 30 days after liver resection)
- Operation time(min)(intraoperative)
- Blood loss(ml)(up to 30 days after liver resection)
- Composite endpoint of liver surgery specific morbidity(up to 1 year after liver resection)
- Hospital and societal costs(up to 1 year after liver resection)
- Change of serum glutamic oxalacetic transaminase(up to 7 days after liver resection)
- Incidence of incisional hernias(up to 1 year after liver resection)
- Change of serum glutamic-pyruvic transaminase(up to 7 days after liver resection)
- C-reactive protein (mg/mL)(up to 5 days after liver resection)
研究者
hui hou
general surgery
The Second Hospital of Anhui Medical University