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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Da Vinci SP intervnetion group | Experimental | for patients who received Da Vinci SP robotic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung Anatomic Resection (Da Vinci SP) | Device | To evaluate the performance and safety of the da Vinci SP® Surgical System in anatomical lung resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day follow-up | Complications (assed according to CTCAE) | Post-operative data through 30-day follow-up |
| Questionnaire assessment (1) | Enrolled subjects would be assessed by pain scale score at baseline (preoperatively), during inpatient phase. Neuropathic pain assessment (Assessment of post-VATS surgery neuralgia- pain DETECT Questionnaire), performed during inpatient phase (Post-operation 1 day, 2 days and day of discharge) and 1 week, 1,3,6,12 months after discharge. |
Inclusion Criteria:
Age >20 and <75 years-old
Willing and able to provide informed consent
ASA≤ 3
The subject is undergoing the following procedures
Preoperative platelet count 150-400 (1000/ uL)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yin Kai Chao, MD,PHD | CHENG GUNG MEMORIAL HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memeorial Hospital, Linkou Medical Center | Taoyuan | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38899114 | Derived | Cheng C, Tagkalos E, Ng CB, Hsu YC, Huang YY, Wu CF, Chao YK. Subcostal uniportal robotic anatomic lung resection: A pilot trial. JTCVS Tech. 2024 Apr 28;25:160-169. doi: 10.1016/j.xjtc.2024.01.024. eCollection 2024 Jun. |
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clinical lung cancer who receive Da Vinci sp robotic surgery
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| Peri-operative parameters |
Operation time (minute), docking time (minute), console time(minute), anesthesia time(minute), Time from recovery room to ward (minute) |
| From Surgery to ward,2- day |
| Peri-operative parameters: blood loss related | which include bloods loss(ml) during operation, blood transfusion (ml) during surgery | During surgery |
| Hospitalization parameters | which include, length of hospital stay (day) | 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 | During Hospitalization, an average of 4 days |
| Patient disposition immediately after surgery | ICU, ward | During Hospitalization, an average of 1 day |
| Through study completion, an average of 1 year |
| Questionnaire assessment (2) | Enrolled subjects would be assessed by numbness score at baseline (preoperatively), during inpatient phase. Neuropathic pain assessment (Assessment of post-VATS surgery neuralgia- pain DETECT Questionnaire), performed during inpatient phase (Post-operation 1 day, 2 days and day of discharge) and 1 week, 1,3,6,12 months after discharge. | Through study completion, an average of 1 year |
| 90-day follow up (1) | Complications (assed according to CTCAE) | Post-operative data through 90-day follow-up |
| Pathological Report | pathologic tumor staging, surgical margins | Post-operative data through 30-day follow-up |
| 90-day Follow up (2) | Unplanned procedure-related reoperations or readmissions, mortality | Post-operative data through 90-day follow-up |