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

Not Applicable

• Conditions: Prostatectomy; Nephrectomy; Robotic Surgical Procedures
• Interventions: Procedure: MicroPort® robot-assisted laparoscopic surgery; Procedure: da Vinci robot-assisted laparoscopic surgery

• Registration Number: NCT04404738
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Study Start: 2020-06-29
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-30
• Last Update Posted: 2020-09-01
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MicroPort® Surgical System	MicroPort® robot-assisted laparoscopic surgery	robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using MicroPort® surgical system
da Vinci Surgical System	da Vinci robot-assisted laparoscopic surgery	robot-assisted surgeries, for instance, prostatectomy, cystectomy or nephrectomy will be performed using da Vinci surgical system

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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.
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.
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.
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 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.

Trial Locations

Locations (4)

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, China