Robot-assisted Urological Surgeries Using the MicroHand S Robot: a Prospective, Single Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Success rate of the surgery
研究概览
简要总结
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.
详细描述
Objective: To determine whether the newly developed Chinese Micro Hand S surgical robot results in non-inferiority outcomes in partial nephrectomy, radical cystectomy, and radical prostatectomy, compared with the prevalent da Vinci robot.
Design: A single-blinded, prospective randomized parallel controlled clinical trial 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.
Interventions: Robot-assisted urological surgeries, such as partial nephrectomy, radical cystectomy, and radical prostatectomy will be conducted using the Micro Hand S robot or the da Vinci robot.
Main measures: The main outcome was the success rate of operation. Surgical success was defined as that the surgical procedures were completed by the experimental or control product without transferring to non-robotic surgery. Secondary outcomes included intra- and post-operative complications, comprehensive complication index, assembly time, operation time, intraoperative hemorrhage, postoperative pain, resident time, surgeon satisfaction, incidence of adverse events, instrument malfunction, vital signs, routine blood test, hepatic and liver function.
Background:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
single-blind
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Success rate of the surgery
时间窗: after the study is completed, up to 18 months
the proportion of patients with successful operation in all participating patients in the experimental or control group
次要结局
- assembly time(after the robot is assembled, all data will be collected within 18 months)