Randomized Open Label Two Arms Cohort Study to Evaluate Curative Effect and Quality of Life of Single Port and Two Ports Robotic Assisted Thoracic Surgery for Thymectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post operation pain
研究概览
简要总结
Recently, robotic-assisted thoracic surgery (RATS) has become into as an alternative approach to either, open surgery or video-assisted thoracoscopic surgery. The superiorities of RATS have been reported in series studies, such as intuitive movements, tremor filtration, more degrees of manipulative freedom, motion scaling, and high-definition stereoscopic vision.
However, the currently reported robotic thymectomy used 3 ports. Theoretically, less incisions may bring faster postoperative recovery, lighter postoperative pain and higher postoperative quality of life. The investigators have successfully performed robotic thymectomy through 2 ports and even 1 port. However, the potential benefit of less ports robotic thymectomy has not been verified through well-designed cohort study, so this clinical trial has been designed.
详细描述
The gold standard technique for thymectomy used to be transsternal approach. Advancements in modern technology bring many evolutions in minimally invasive surgery such as Video-assisted thoracic surgery (VATS) thymectomy gained popularity after 2000s. Recently, robotic-assisted thoracic surgery (RATS) has become into as an alternative approach to either, open surgery or video-assisted thoracoscopic surgery. The superiorities of RATS have been reported in series studies, such as intuitive movements, tremor filtration, more degrees of manipulative freedom, motion scaling, and high-definition stereoscopic vision.
However, the currently reported robotic thymectomy used 3 ports. Theoretically, less incisions may bring faster postoperative recovery, lighter postoperative pain and higher postoperative quality of life. The investigators have successfully performed robotic thymectomy through 2 ports and even 1 port. However, the potential benefit of less ports robotic thymectomy has not been verified through well-designed cohort study, so this clinical trial has been designed.
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
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Myasthenia Gravis and(or) thymoma need to perform thymectomy.
- •Agree to accept Robotic Assisted Thoracic Surgery and have signed informed consent.
排除标准
- •Cardiopulmonary function cannot tolerate thoracoscopic surgery or exist other contraindication.
- •Thymic carcinoma.
- •Thoracic deformity.
结局指标
主要结局
Post operation pain
时间窗: 1 month after surgery
Measured with Visual Analogue Score (VAS-score),the minimum value is 1, the maximum value is 10, higher scores mean a worse outcome.
次要结局
- Curative effect(5 years)
- Surgical bleeding(During operation)
- Operation duration(During operation)
- Quality of life after surgery(6 months)
研究者
Lei Jiang
principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
