MARS: MicroPort® Endoscopic Instrument Control System to Accomplish Robotic-assisted Surgery in Urology
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MicroPort® Surgical System robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using MicroPort® surgical system |
Procedure: MicroPort® robot-assisted laparoscopic surgery
In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by Microport® Surgical System
|
| Active Comparator: da Vinci Surgical System robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using da Vinci surgical system |
Procedure: da Vinci robot-assisted laparoscopic surgery
In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by da Vinci Surgical System
|
Outcome Measures
Primary Outcome Measures
- surgical success rate [24 hours following the surgery]
Surgery is completed without conversion to other operations and without a re-operation caused by intraoperative complications within 24 hours
Secondary Outcome Measures
- blood loss [during the surgery]
Amount of intraoperative bleeding in the patient from the start to the end of the operation
- operative time [during the surgery]
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.
- length of hospital stay [24 hours after discharge]
The total hospital days of subjects from the day of the operation to discharge.
- perioperative complication rate [2 weeks after operation]
The overall incidence of intraoperative and postoperative complications.
- The physiological load of the surgeon during the surgery [immediately after 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.
- The psychological load of the surgeon during the surgery [immediately after 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.
- the critical failure rate of the robotic system [during the surgery]
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
- the recoverable malfunction rate of the robotic system [during the surgery]
Recoverable malfunction meant minor errors that could be easily resolved by the technician and has no significant impact on the process or the operation
- Instrument performance [immediately after the surgery]
The researcher fills in the instrument performance evaluation form after the operation to review the performance of the instrument during the test.
Eligibility Criteria
Criteria
Inclusion Criteria:
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be aged between 18 years and 80 years;
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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
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being 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 consent.
Exclusion Criteria:
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patients requiring emergency surgery;
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have severe cardiovascular or circulatory disease and cannot tolerate surgery;
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participated in other clinical trials in the last 3 months;
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failure to understand study requirements
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | China | ||
| 2 | The first affiliated hospital of naval medical university (Shanghai changhai hospital) | Shanghai | China | ||
| 3 | Zhongshan Hospital Affiliated to Fudan University | Shanghai | China | ||
| 4 | Zhejiang Provincial People's Hospital | Zhejiang | China |
Sponsors and Collaborators
- Changhai Hospital
Investigators
- Principal Investigator: Xu Gao, professor, Changhai Hospital
- Principal Investigator: Jianming Guo, professor, Shanghai Zhongshan Hospital
- Principal Investigator: Wei Xue, professor, RenJi Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MPMB-2019-MKW