Thoracic Surgery by the Medtronic Hugo™ Robotic System

Официальное название

Thoracic Surgery by the Medtronic Hugo™ Robotic System: A Prospective Single Centre Study

Обзор

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.

Вмешательства

• Устройство Medtronic Hugo™ surgical robotic system
  undergoing robotic thoracic surgery by the Medtronic Hugo™ surgical robotic system

Первичные конечные точки

• The conversion rate [Срок оценки: 1 year]
• The peri-operative complication [Срок оценки: 1 year]

Вторичные конечные точки (5)

• Completeness of Resection evaluated by histopathological analysis [Срок оценки: 1 month]
• Resection margin measured by histopathological methods [Срок оценки: 1 month]
• Number of Lymph Nodes Harvested assessed through pathological examination [Срок оценки: 1 month]
• Clinical Recurrence investigated through follow-up imaging [Срок оценки: 1 year]
• Functional outcome (pre and post lung function test) will be collected [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Гонконг · 1 центр

• Prince of Wales Hospital — Гонконг

Идентификаторы

NCT: NCT06669104 · CUHK HUGO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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