Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- conversion rate to open surgery
研究概览
简要总结
To compare the safety/efficacy of the robotic-assisted lobectomy/segmentectomy (RAL/S) with the video-assisted lobectomy/segmentectomy (VAL/S) for lung resection.
Video-assisted lobectomy/segmentectomy (VAL/S) for lung resection is divided into uniport group and multiple- port group.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •good cardio- pulmonary function to tolerate surgery;
- •minimaly invasive surgery for lobectomy or segmentectomy or sleeve lobectomy;
排除标准
- •cardio- pulmonary function is not good enough to tolerate surgery;
- •huge tumor or extensive adhesion in thoracic cavity.
结局指标
主要结局
conversion rate to open surgery
时间窗: during surgery
incidence rate
days to tube removal
时间窗: within 7 days after surgery
days
mortality
时间窗: 30 days after surgery
incidence rate
retrieved lymph node station
时间窗: within 1 days after surgery
amount
postoperative complications
时间窗: within 7 days after surgery
incidence rate
duration of hospitalization
时间窗: within 7 days after surgery
days
retrieved lymph node
时间窗: within 1 days after surgery
amount
short- term PFS
时间窗: 3 years
proportion
operation time
时间窗: within 180 minutes
minutes
short- term overall survival
时间窗: 3 years
proportion
次要结局
未报告次要终点