This is the first human clinical study for explore the feasibility of lung anatomic resection through Da Vinci SP surgical platform
During the past several years, minimally invasive thoracic surgery has evolved from thoracoscopic approaches using 3 -4 ports to a single incision video-assisted thoracoscopic surgery (VATS) techniques. Recently, the experience acquired with the uniportal VATS technique through the intercostal space has allowed the development of a uniportal VATS subxiphoid or subcostal approach for major pulmonary resections. The advantage of using a subxiphoid or subcostal entry is to reduce pain by avoiding possible trauma of intercostal nerves caused by thoracic incisions. However, the longer distance from the subxiphoid or subcostal incision to the hilum makes this approach more difficult to perform anatomical pulmonary resections.During this same period of evolution into uniportal VATS surgery, robotic thoracic surgery has gained popularity as an alternative to traditional VATS. The advantages of robotics are the ability to perform surgery more precisely with articulated or wristed instruments, motion scaling, and tremor filtration, as well as improved visualization thanks to 3D high-definition video. However, currently 4 -5 incisions are still necessary to perform anatomic robotic resections.Recently, there has been a convergence of these two trends-uniportal surgery and robotic-assisted surgery-and has resulted in a single port robotic system, the da Vinci SP by Intuitive Surgical Cooperation. For this new platform, investigators plan to practice in thoracic anatomic lung resection
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
To evaluate the performance and safety of the da Vinci SP® Surgical System in anatomical lung resection
Chang Gung Memeorial Hospital, Linkou Medical Center
Taoyuan District, Taiwan
Incidence of conversion rate
The primary performance endpoint will be assessed as the ability to successfully complete the planned anatomic resection procedure with the da Vinci SP System, with no conversion to thoracoscopic, multi-port robotic, or open surgery. Usage of additional assistant port(s) is not considered a conversion.
Time frame: During Surgery
Incidence of Treatment Related Adverse Events
The primary safety endpoint will be assessed as the incidence of all intra-operative and post-operative adverse events that occur within the study follow-up period. Complications are assessed using the Common Terminology Criteria for Adverse Events, CTCAE.
Time frame: One Year
Peri-operative parameters
Operation time (minute), docking time (minute), console time(minute), anesthesia time(minute), Time from recovery room to ward (minute)
Time frame: From Surgery to ward,2- day
Peri-operative parameters: blood loss related
which include bloods loss(ml) during operation, blood transfusion (ml) during surgery
Time frame: During surgery
Hospitalization parameters
which include, length of hospital stay (day)
Time frame: During Hospitalization, an average of 4 days
Operative related complications during hospitalization
which include in-hospital mortality and morbidity, reasons need for reoperation, unplanned procedure after surgery
Time frame: During Hospitalization, an average of 4 days
Patient disposition immediately after surgery
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ICU, ward
Time frame: During Hospitalization, an average of 1 day