MicroPort® Endoscopic Instrument Control System to Accomplish Robotic-assisted Surgery in Urology

Study Overview
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Brief Summary
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Laparoscopy, now virtually completely, was replaced with robotic surgery in uro-oncological surgery in the world. And given the significant increase in the number of robotic surgeries for prostate, bladder and kidney cancer, it is now a major domain in oncological surgery. Microport MedBot Inc. has independently developed a domestic surgical robot in China. Therefore, the purpose of the study is to evaluate the safety and efficacy of the Chinese robot when applied to surgery in oncology.

Official Title
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Clinical Studies of Robotic-assisted Surgery in Urology With MicroPort® Endoscopic Instrument Control System

Conditions
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Prostatectomy, Robotic Surgical Procedures, Nephrectomy

Intervention / Treatment
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* Procedure: MicroPort® robot-assisted laparoscopic surgery
* Procedure: da Vinci robot-assisted laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be aged between 18 years and 80 years; laparoscopic surgery is required with one of the following surgical indications:(1)planning to perform radical prostatectomy(clinical stage is T1 or T2,and PSA≥ 0.2ng/mL) ;(2) planning to perform nephrectomy being able to cooperate and complete the follow-up and related examinations; volunteer to participate in this study and sign the informed consent. Exclusion Criteria: patients requiring emergency surgery; have severe cardiovascular or circulatory disease and cannot tolerate surgery; participated in other clinical trials in the last 3 months; failure to understand study requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MicroPort® Surgical System<br>robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using MicroPort® surgical system | Procedure: MicroPort® robot-assisted laparoscopic surgery<br>* In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by Microport® Surgical System<br>|
| Active Comparator: da Vinci Surgical System<br>robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using da Vinci surgical system | Procedure: da Vinci robot-assisted laparoscopic surgery<br>* In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by da Vinci Surgical System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical success rate | Surgery is completed without conversion to other operations and without a re-operation caused by intraoperative complications within 24 hours | 24 hours following the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | Amount of intraoperative bleeding in the patient from the start to the end of the operation | during the surgery | 
| operative time | The starting point and end point of the operation time are the first effective movement of the robot arm and the movement stop of the robot arm after the operation. | during the surgery | 
| length of hospital stay | The total hospital days of subjects from the day of the operation to discharge. | 24 hours after discharge | 
| perioperative complication rate | The overall incidence of intraoperative and postoperative complications. | 2 weeks after operation | 
| The physiological load of the surgeon during the surgery | The physiological load is assessed by the LED scale immediately after the surgery. LED is the local experienced discomfort scale used to assess the intraoperative physiological load of different parts of the surgeon's body. There are 10 points in the scale, and higher score means worse, with 0 means no discomfort and 10 is the worst discomfort. | immediately after the surgery | 
| The psychological load of the surgeon during the surgery | The psychological load is assessed by the SME scale immediately after the operation. SME scale is the subjective mental effort scale used to assess the intraoperative psychological load of the surgeon. The scale has a total of 150 points, with a scale of 10 points. The higher the score, the worse it is, with 0 means no any difficult and above 110 points means extremely difficult. | immediately after the surgery | 
| the critical failure rate of the robotic system | Critical failures that are difficult to repair in a short period of time during robot-assisted surgery and can have a serious impact on the process or the operation | during the surgery | 
| the recoverable malfunction rate of the robotic system | Recoverable malfunction meant minor errors that could be easily resolved by the technician and has no significant impact on the process or the operation | during the surgery | 
| Instrument performance | The researcher fills in the instrument performance evaluation form after the operation to review the performance of the instrument during the test. | immediately after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, urology, robot, efficacy