Thoracic Surgery by the Medtronic Hugo™ Robotic System: A Prospective Single Centre Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The conversion rate
研究概览
简要总结
The introduction of robot-assisted surgery is one of the biggest breakthroughs in surgery, and represents the most significant advancement in minimally invasive surgery of recent decades. One of the first surgical uses of the robot was in orthopaedics, neurosurgery and cardiac surgery. However, it's use has now been well recognized in thoracic surgical procedures ranging from mediastinal tumour resection to complex major lung resections.
Robotic surgery by the da Vinci Surgical System (Intuitive Surgical, Inc) has been one of the most commonly used robotic systems in surgery. The robotic system overcomes the limitations of the standard thoracoscopic approach and allows for precise dissection in a confined space. These advantages include stable operator-controlled camera, high- definition 3D magnified view of 10 to 12 times, articulating instruments with seven degrees of freedom, motion scaling, and tremor filtration.
Recently the Medtronic Hugo™ surgical robotic system has passed the CE mark. This robotic platform, made up of modular surgical arms on wheeled carts, has started its operation in human in Latin America, Europe and the Asia-Pacific region. The Hugo™ system is designed to provide a lower barrier to entry for hospitals looking to expand their reach in robotic surgery. Compared to the platform by Intuitive Surgical, Hugo™can be customized with up to four independent arms, and rolled to different locations in a hospital when needed.
The investigator's centre is the first robotic surgical centre in Hong Kong since 2005. Over the years, the investigator have established the centre to be one of the leading centre in Hong Kong and the region, with involvement in various new development in thoracic robotic procedures, publications and books, and more recently in robotic endo-lumenal procedures.
In this study, the investigator evaluate the early surgical outcome and objective functional outcome of patients undergoing robotic thoracic surgery by the Medtronic Hugo™ surgical robotic system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age between 18 - 80 years
- •Body mass index <35 kg/m2
- •Suitable for minimally invasive surgery
- •Willingness to participate as demonstrated by giving informed consent
排除标准
- •Contraindication to general anaesthesia
- •Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- •Untreated active infection
- •Non-correctable coagulopathy
- •Emergency surgery
- •Vulnerable population (e.g. mentally disabled, pregnancy)
结局指标
主要结局
The conversion rate
时间窗: 1 year
The feasibility of the Medtronic Hugo™ robotic system for thoracic robotic procedures (anterior mediastinal tumour resection, posterior mediastinal tumour resection and lung resection (wedge, segmentectomy, lobectomy), as measured by the conversion rate
The peri-operative complication
时间窗: 1 year
The safety profile of the Medtronic Hugo™ robotic system for thoracic robotic procedures (anterior mediastinal tumour resection, posterior mediastinal tumour resection and lung resection (wedge, segmentectomy, lobectomy), as measured by the peri-operative complication profile.
次要结局
- Completeness of Resection evaluated by histopathological analysis(1 month)
- Resection margin measured by histopathological methods(1 month)
- Number of Lymph Nodes Harvested assessed through pathological examination(1 month)
- Clinical Recurrence investigated through follow-up imaging(1 year)
- Functional outcome (pre and post lung function test) will be collected(1 year)
研究者
Calvin Sze Hang Ng
Professor
Chinese University of Hong Kong