A Study to Evaluate Safety and Feasibility of Robotic Liver Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Postoperative unplanned reoperation
研究概览
简要总结
The robotic surgery system, the most advanced technology in minimally invasive surgery, overcame some shortcomings of laparoscopic surgery and improved the flexibility and precision of liver resection. Several studies have demonstrated that the robotic system was safe and feasible in liver surgery and might be advantageous in complex hepatic vein and hilar dissection, operative bleeding control, and biliary reconstruction. Previous comparative studies found limited evidence for significantly improved outcomes in robotic liver resection (RLR) over laparoscopic liver resection (LLR) or open liver resection (OLR), considering the various degrees of difficulty in liver surgeries.
This study aimed to evaluate safety and feasibility of robotic liver resection, by comparing it with LLR or OLR, and gain veritable and relevant data on the benefits of RLR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The patients were diagnosed with a liver tumor.
- •The patients underwent robotic liver resection.
排除标准
- •The patients underwent simultaneous malignancy resection of the colorectum or other organs (except gallbladder).
结局指标
主要结局
Postoperative unplanned reoperation
时间窗: with in 90 days after surgery
The unplanned reoperation due to postoperative complications
Unplanned readmission
时间窗: with in 90 days after surgery
The unplanned readmission after discharge due to postoperative complications
Postoperative complications
时间窗: with in 90 days after surgery
The grades of postoperative complications were recorded following the Clavien-Dindo classification. Partial hepatic dysfunction or hepatic failure, biliary fistula, postoperative hemorrhage, pleural effusion, venous thrombosis, and surgical site infections were recorded.
Postoperative hospital stay
时间窗: with in 90 days after surgery
The days of hospital stay after operation
次要结局
未报告次要终点
研究者
TingBo Liang
Professor
Zhejiang University