Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000).
- Conditions
- Urologic Neoplasms
- Registration Number
- NCT05025930
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
- Any male or female age from 18 to 80
- BMI 18-30kg/m2
- Have urological surgery indications (cystectomy, prostatectomy, and nephrectomy)
- Patients with physiologic conditions capable of receiving laparoscopic surgery
- Be able to cooperate and complete the follow-up and related examinations
- Volunteer to participate in this study and sign the informed consen
- The researchers assess patients with severe cardiovascular or circulatory disease and cannot tolerate the surgery
- History of epilepsy or mental illness
- Pregnant and lactation
- Surgery history at the relevant surgical site, which is considered to influence surgical procedures
- Severe allergic or addiction of drug and alcohol
- Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastasis disease
- Inability to understand the trial or complete the follow-up
- Participated in other therapeutic clinical trials within 90 days
- Patients who had undergone major operation and major trauma within 28 days prior to enrollment, which the researchers considered to have an impact on the outcome of surgery
- Patients deemed unsuitable to participate in this trial by researchers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of serious adverse events during clinical trial 3 months Surgical success rate 24 hours 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
- Secondary Outcome Measures
Name Time Method Operative time 12 hours Machine installation time preoperative Time from sheeting to complete the installation of surgical instruments
Changes in prostate-specific antigen levels 3 months Changes in prostate-specific antigen levels will be measured after surgery for patients who undergone radical prostatectomy
Tumor recurrence rate 3 months Perioperative complication rate 3 months Perioperative complication will be graded using the Clavien-Dindo Complication Classification. The proportion and severity of perioperative complications will be analyzed
Changes in serum creatinine 3 months Evaluating renal function by changes in serum creatinine after surgery for partial or radical nephrectomy
Pain after surgery 24 hours Visual analogue scale as a monitoring tool for postoperative pain
Surgeon Satisfaction 12 hours NASA-TLX quantification table will be used to evaluate surgeon satisfaction after surgery
Blood loss during the surgery 12 hours Margin positive rate 1 month
Trial Locations
- Locations (1)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China