Clinical trial NCT06669104: Thoracic Surgery by the Medtronic Hugo™ Robotic System
Official title: Thoracic Surgery by the Medtronic Hugo™ Robotic System: a Prospective Single Centre Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracic Cancer
Keywords: robotic assisted thoracic surgery
minimally invasive surgery
lung cancer
mediastinal tumour
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are advised to have robotic thoracic procedures

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 - 80 years
2. Body mass index \<35 kg/m2
3. Suitable for minimally invasive surgery
4. Willingness to participate as demonstrated by giving informed consent

Exclusion Criteria:

1. Contraindication to general anaesthesia
2. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
3. Untreated active infection
4. Non-correctable coagulopathy
5. Emergency surgery
6. Vulnerable population (e.g. mentally disabled, pregnancy)

Primary outcomes:
measure: The conversion rate
timeFrame: 1 year
measure: The peri-operative complication
timeFrame: 1 year
Secondary outcomes:
measure: Completeness of Resection evaluated by histopathological analysis
timeFrame: 1 month
measure: Resection margin measured by histopathological methods
timeFrame: 1 month
measure: Number of Lymph Nodes Harvested assessed through pathological examination
timeFrame: 1 month
measure: Clinical Recurrence investigated through follow-up imaging
timeFrame: 1 year
measure: Functional outcome (pre and post lung function test) will be collected
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: CUHK
name: Calvin Sze Hang Ng
role: PRINCIPAL_INVESTIGATOR
References: