Clinical trial NCT04404738: MicroPort® Endoscopic Instrument Control System to Accomplish Robotic-assisted Surgery in Urology
Official title: Clinical Studies of Robotic-assisted Surgery in Urology With MicroPort® Endoscopic Instrument Control System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Robotic Surgical Procedures
Prostatectomy
Nephrectomy
Keywords: robot
efficacy
safety
urology
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: surgical success rate
timeFrame: 24 hours following the surgery
Secondary outcomes:
measure: blood loss
timeFrame: during the surgery
measure: operative time
timeFrame: during the surgery
measure: length of hospital stay
timeFrame: 24 hours after discharge
measure: perioperative complication rate
timeFrame: 2 weeks after operation
measure: The physiological load of the surgeon during the surgery
timeFrame: immediately after the surgery
measure: The psychological load of the surgeon during the surgery
timeFrame: immediately after the surgery
measure: the critical failure rate of the robotic system
timeFrame: during the surgery
measure: the recoverable malfunction rate of the robotic system
timeFrame: during the surgery
measure: Instrument performance
timeFrame: immediately after the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: The first affiliated hospital of naval medical university (Shanghai changhai hospital)
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
city: Zhejiang
country: China
facility: Zhejiang Provincial People's Hospital
Study officials:
affiliation: Changhai Hospital
name: Xu Gao, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Zhongshan Hospital
name: Jianming Guo, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: RenJi Hospital
name: Wei Xue, professor
role: PRINCIPAL_INVESTIGATOR
References: