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

Nephrectomy Clinical Trial

— MARS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04404738
• Other study ID #: MPMB-2019-MKW
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: December 2022

Study information

• Verified date: August 2020
• Source: Changhai Hospital
• Contact: Xu Gao, professor
• Phone: 0086-021-31161718
• Email: gaoxu.changhai[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Nephrectomy
• Prostatectomy
• Robotic Surgical Procedures

Intervention

Procedure:
• MicroPort® robot-assisted laparoscopic surgery
In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by Microport® Surgical System
• 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

Locations

Country	Name	City	State
China	Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai
China	The first affiliated hospital of naval medical university (Shanghai changhai hospital)	Shanghai
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai
China	Zhejiang Provincial People's Hospital	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	blood loss	Amount of intraoperative bleeding in the patient from the start to the end of the operation	during the surgery
Secondary	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
Secondary	length of hospital stay	The total hospital days of subjects from the day of the operation to discharge.	24 hours after discharge
Secondary	perioperative complication rate	The overall incidence of intraoperative and postoperative complications.	2 weeks after operation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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