Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000).
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: endoscopic surgical instrument control system (SP1000: single- port laparoscopy) Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (SP1000) |
Device: endoscopic surgical instrument control system (SP1000: single-port laparoscopy)
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.
|
| Active Comparator: Comparator: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy) Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (IS3000) |
Device: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Incidence of serious adverse events during clinical trial [3 months]
Secondary Outcome Measures
- 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
- 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]
- Machine installation time [preoperative]
Time from sheeting to complete the installation of surgical instruments
- Operative time [12 hours]
- Blood loss during the surgery [12 hours]
- Margin positive rate [1 month]
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Any male or female age from 18 to 80
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BMI 18-30kg/m2
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Have urological surgery indications (cystectomy, prostatectomy, and nephrectomy)
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Patients with physiologic conditions capable of receiving laparoscopic surgery
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Be able to cooperate and complete the follow-up and related examinations
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Volunteer to participate in this study and sign the informed consen
Exclusion Criteria:
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The researchers assess patients with severe cardiovascular or circulatory disease and cannot tolerate the surgery
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History of epilepsy or mental illness
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Pregnant and lactation
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Surgery history at the relevant surgical site, which is considered to influence surgical procedures
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Severe allergic or addiction of drug and alcohol
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Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastasis disease
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Inability to understand the trial or complete the follow-up
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Participated in other therapeutic clinical trials within 90 days
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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
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Patients deemed unsuitable to participate in this trial by researchers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China | 510120 |
Sponsors and Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Chinese PLA General Hospital
- The First Affiliated Hospital of Nanchang University
- Edge Medical Robotics CO.,LTD
Investigators
- Principal Investigator: Tianxin Lin, MD, Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SysMU-Robot