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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
| Edge Medical Robotics CO.,LTD | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoscopic surgical instrument control system (SP1000: single- port laparoscopy) | Experimental | Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (SP1000) |
|
| Comparator: endoscopic surgical instrument control system (IS3000: multi-port laparoscopy) | Active Comparator | Urological surgery procedures such as prostatectomy, and partial or radical nephrectomy will be performed using endoscopic surgical instrument control system (IS3000) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic surgical instrument control system (SP1000: single-port laparoscopy) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours |
| Incidence of serious adverse events during clinical trial | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative complication rate | Perioperative complication will be graded using the Clavien-Dindo Complication Classification. The proportion and severity of perioperative complications will be analyzed | 3 months |
| Changes in serum creatinine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaiwen Li, MD | Contact | +86-02034078960 | likw6@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Tianxin Lin, MD | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China |
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|
| endoscopic surgical instrument control system (IS3000: multi-port laparoscopy) | Device | 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. |
|
Evaluating renal function by changes in serum creatinine after surgery for partial or radical nephrectomy
| 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 | 3 months |
| Tumor recurrence rate | 3 months |
| Machine installation time | Time from sheeting to complete the installation of surgical instruments | preoperative |
| Operative time | 12 hours |
| Blood loss during the surgery | 12 hours |
| Margin positive rate | 1 month |
| Pain after surgery | Visual analogue scale as a monitoring tool for postoperative pain | 24 hours |
| Surgeon Satisfaction | NASA-TLX quantification table will be used to evaluate surgeon satisfaction after surgery | 12 hours |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |
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