Thoracic Surgery by SHURUI Single-Port Surgical Robot

The feasibility of the Endoscopic Surgical System, SR-ENS-600 for thoracic robotic procedures (Lobectomy, Segmentectomy Wedge resection of lung and Mediastinal Tumour Resection), as measured by the conversion rate

The safety profile of the Endoscopic Surgical System, SR-ENS-600 for thoracic robotic procedures (Lobectomy, Segmentectomy Wedge resection of lung and Mediastinal Tumour Resection), as measured by the peri-operative complication profile.

The time from the beginning of the teleoperation to the ending of the teleoperation. Note: 1) the time of starting the skin incision, 2) the time of the surgical trolley parking, 3) the time of the positioning connection, 4) the time of starting teleoperation, 5) the time of finishing teleoperation, 6) the time of the closing skin incision.

The operation-related time can reflect the maneuverability and ease of use of the instrument. Because the time of equipment preparation, skin incision, positioning connection and so on are interfered by many factors in the operating room, and the time from the beginning of teleoperation to the end of teleoperation is relatively stable, therefore, it is more objective to collect and analyze this period of time.

Amount of intraoperative blood loss is recorded from the beginning to the end of the surgery

Total length of stay from the day of surgery to discharge. For subjects admitted in the afternoon/ discharged in the morning, 0.5 days were recorded on the day of admission/discharge.

time window: 24 ± 4 hours after surgery, 72 ± 4 hours after surgery, 120 ± 4 hours after surgery. This was assessed using the numerical rating scale (NRS) . The NRS score is clear and objective, which can help subjects make more accurate assessments and improve the comparability of assessments between different subjects. It was once considered the gold standard for pain assessment by the American Society of Pain[11]. This investigation used NRS versions 0-10, the most commonly used NRS (Figure. 5-1) . The subjects were assigned to 4 categories with 11 scores (0-10) : No Pain (0) , mild pain (1-3) , moderate pain (4-6) , and severe pain (7-10) . If the subject is discharged before a certain evaluation time point, the evaluation at that time point and after can not be carried out.

Proportion of subjects who underwent an intraoperative blood transfusion.

time window: day 0 ~ within 24 hours after surgery. The Surgeon Satisfaction Questionnaire consists of two parts: the system (the"System" in this questionnaire refers to the investigational device "Endoscopic surgical system") performance-related (items 1 to 12, total of 12) and the surgeon comfort-related score (items 13 to 20, total of 8) . The Rating Scale: 5 points for each question, 1-5 points from top to bottom, full score of 100 points.

Surgical complication rates [ time window: within 30 ± 7 days after surgery] Possible intraoperative complications include thoracic adhesion, intraoperative bleeding, airway injury, and nerve injury. Possible postoperative complications include: pulmonary complications (including persistent air leak, pneumonia, atelectasis, pleural effusion, respiratory insufficiency/respiratory failure, etc.) , recurrent laryngeal nerve paralysis, chylothorax, etc.

Incidence of device defects time window: the day of surgery. Device defect refers to the unreasonable risks that may endanger human health and safety, such as wrong label, quality problem, malfunction, etc.

for operations other than segmentectomy/lobectomy reasons, not counted as reoperation rate

for reasons other than segmentectomy/lobectomy, not counted as the rate of reoperation

Mortality within 30 days after surgery