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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by Microport® Surgical System
In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by da Vinci Surgical System
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
RECRUITINGThe first affiliated hospital of naval medical university (Shanghai changhai hospital)
Shanghai, China
RECRUITINGZhongshan Hospital Affiliated to Fudan University
Shanghai, China
NOT_YET_RECRUITINGZhejiang Provincial People's Hospital
Zhejiang, China
NOT_YET_RECRUITINGsurgical success rate
Surgery is completed without conversion to other operations and without a re-operation caused by intraoperative complications within 24 hours
Time frame: 24 hours following the surgery
blood loss
Amount of intraoperative bleeding in the patient from the start to the end of the operation
Time frame: 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.
Time frame: during the surgery
length of hospital stay
The total hospital days of subjects from the day of the operation to discharge.
Time frame: 24 hours after discharge
perioperative complication rate
The overall incidence of intraoperative and postoperative complications.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: immediately after the surgery
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