Robot-assisted surgery has been successfully adopted rapidly over the last decade. Robotic technology with tridimensional imaging can improve operating dexterity, visualization of difficult anatomic locations. This is a prospective study aims to evaluate the safety and effectiveness of the domestic surgical robot.
In this clinical trial, the subjects will be randomly divided into two groups, and the urological typical surgical procedures (prostatectomy, and partial or radical nephrectomy) will be performed with the endoscopic surgical instrument control system SP1000 and IS3000.And the non-inferiorly comparison will be made between the surgical results of two systems to verify the safety and effectiveness of the endoscopic surgical instrument control system (SP1000).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
The system will be used in conjunction with other equipment during endoscopic surgery to accurately control endoscopic surgical instruments and perform delicate surgical procedures such as grasping, cutting, blunt separation, hemostasis, ligation and suture.
The system will be used in conjunction with other equipment during endoscopic surgery to accurately control endoscopic surgical instruments and perform delicate surgical procedures such as grasping, cutting, blunt separation, hemostasis, ligation and suture.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Surgical success rate
The surgical success rate was defined as the percentage of patients in the experimental group and the control group who were successfully operated with the systems
Time frame: 24 hours
Incidence of serious adverse events during clinical trial
Time frame: 3 months
Perioperative complication rate
Perioperative complication will be graded using the Clavien-Dindo Complication Classification. The proportion and severity of perioperative complications will be analyzed
Time frame: 3 months
Changes in serum creatinine
Evaluating renal function by changes in serum creatinine after surgery for partial or radical nephrectomy
Time frame: 3 months
Changes in prostate-specific antigen levels
Changes in prostate-specific antigen levels will be measured after surgery for patients who undergone radical prostatectomy
Time frame: 3 months
Tumor recurrence rate
Time frame: 3 months
Machine installation time
Time from sheeting to complete the installation of surgical instruments
Time frame: preoperative
Operative time
Time frame: 12 hours
Blood loss during the surgery
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Time frame: 12 hours
Margin positive rate
Time frame: 1 month
Pain after surgery
Visual analogue scale as a monitoring tool for postoperative pain
Time frame: 24 hours
Surgeon Satisfaction
NASA-TLX quantification table will be used to evaluate surgeon satisfaction after surgery
Time frame: 12 hours