Robot-assisted Urological Surgeries Using the MicroHand S Robot
1 other identifier
interventional
136
1 country
1
Brief Summary
A single-blinded, prospective randomized parallel controlled clinical trial is designed and will be conducted from July 2022 to November 2023 (anticipated). One hundred and thirty-six patients (anticipated) with renal cancer or bladder cancer or prostate cancer will be enrolled in this study. Those patients will be enrolled by two hospital centers and the patients will be randomly divided into the Micro Hand S surgical robot group and the da Vinci surgical robot group. Robot-assisted partial nephrectomy, radical cystectomy, and radical prostatectomy will be conducted using the Micro Hand S robot or the da Vinci robot. The success rate of operation, assembly time, operation time, intraoperative hemorrhage, continence rate (if applicable), postoperative pain, comprehensive complication index, resident time and surgeon satisfaction were recorded. The aim of the study is to determine whether the newly developed Chinese Micro Hand S surgical robot results in non-inferiority outcomes in urological surgeries compared with the prevalent da Vinci robot.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2022
CompletedFirst Posted
Study publicly available on registry
July 18, 2022
CompletedStudy Start
First participant enrolled
July 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 2, 2023
August 1, 2023
1.3 years
July 14, 2022
August 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Success rate of the surgery
the proportion of patients with successful operation in all participating patients in the experimental or control group
after the study is completed, up to 18 months
Secondary Outcomes (1)
assembly time
after the robot is assembled, all data will be collected within 18 months
Other Outcomes (2)
blood loss
after the procedure is completed, all data will be collected within 14 months
The hospital stay
from the admission to the discharge, all data will be collected within 14 months
Study Arms (2)
the Micro Hand S robot group
EXPERIMENTAL68 patients were randomly allocated in the Micro Hand S robot group and partial nephrectomy, radical cystectomy, and radical prostatectomy will be performed using the Micro Hand S robot.
the da Vinci robot group
OTHER68 patients were randomly allocated in the da Vinci robot group and partial nephrectomy, radical cystectomy, and radical prostatectomy will be performed using the da Vinci robot.
Interventions
urological surgeries, such as partial nephrectomy, radical cystectomy, and radical prostatectomy was performed for patients using the Micro Hand S robot group.
Eligibility Criteria
You may qualify if:
- BMI was 18-30 kg/m2;
- patients that need partial nephrectomy, radical cystectomy, and radical prostatectomy.
- patients that understand the benefits and risks of this test, and are willing to participate and sign the informed consent form
You may not qualify if:
- Previous abdominal and pelvic surgery history (preoperative evaluation may affect this operation)
- People with serious uncontrolled diseases or acute infections, including but not limited to: Patients with active tuberculosis and HIV antibody positive; Those who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and whose copy number of hepatitis B virus DNA (HBV-DNA) is higher than the lower limit of detection or the range of normal values; Hepatitis C virus (HCV) antibody positive; Treponema pallidum positive patients; Covid-19 positive patients
- Long term use of anticoagulant and antiplatelet drugs (antiplatelet aggregation drugs were stopped less than 1 week before operation), and patients with a history of hemorrhagic diseases or hematopoietic dysfunction or coagulation dysfunction; Serious allergic constitution and suspected or confirmed alcohol, drug or drug addiction; Patients with epilepsy or mental history or cognitive impairment
- Patients with cardiovascular and cerebrovascular diseases, blood system diseases, or poor control of blood glucose and blood pressure, who cannot tolerate anesthesia or increase the risk of surgery according to the evaluation of the researcher
- women in pregnancy or lactation
- Patients who have participated or are participating in clinical research of other drugs, biological agents or medical devices in the past 3 months
- Other conditions that the researcher believes are not suitable to participate in this experiment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- single-blind
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2022
First Posted
July 18, 2022
Study Start
July 28, 2022
Primary Completion
November 1, 2023
Study Completion
December 1, 2023
Last Updated
August 2, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share