Robotic Cholecystectomy Using the Newly Developed Chinese Robotic Surgical System-Micro Hand S: A Controlled, Randomized, Prospective Clinical Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 82
- 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 was designed and conducted from December 2019 to November 2020. 82 patients with a gallstone, gallbladder polyp and other benign gallbladder diseases were enrolled in this study. Finally, 82 patients were randomly divided into the Micro Hand S surgical robot group and the da Vinci surgical robot group. Standard robot-assisted transabdominal cholecystectomy was conducted using the Micro Hand S robot or the da Vinci robot. The success rate of operation, assembly time, operation time, intraoperative hemorrhage, time to first flatus, postoperative pain, comprehensive complication index, resident time and patient satisfaciton 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 cholecystectomy 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 cholecystectomy compared with the prevalent da Vinci robot.
Design: A single-blinded, prospective randomized parallel controlled clinical trial was designed and conducted from December 2019 to November 2020. The study was conducted in an academic hospital. 82 patients with a gallstone, gallbladder polyp and other benign gallbladder diseases were enrolled in this study. Finally, 82 patients were randomly divided into the Micro Hand S surgical robot group and the da Vinci surgical robot group.
Interventions: Standard robot-assisted transabdominal cholecystectomy was conducted using the Micro Hand S robot or the da Vinci robot.
Main outcomes and 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 assembly time, operation time, intraoperative hemorrhage, time to first flatus, postoperative pain, comprehensive complication index, resident time and patient satisfaction.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •from 18 to 65 years old;
- •patients with acute or chronic cholecystitis, gallstone, gallbladder polyp and other benign gallbladder diseases;
- •BMI was 18-30 kg/m2;
- •the American Society of Anesthesiologists (ASA) classification was I, II, or III.
排除标准
- •women in pregnancy or lactation;
- •A history of epilepsy or mental illness;
- •Previous relevant operation history;
- •Patients with a severe cardiovascular and cerebrovascular disease with New York Heart Association (NYHA) classification III-IV and pulmonary insufficiency who cannot tolerate the operation;
- •Liver cirrhosis, kidney failure and other severe liver and kidney dysfunction (ALT and AST exceeded 3 times of the upper limit of normal value, Cr exceeded 1.5 times of the upper limit of normal value).
结局指标
主要结局
Success rate of the surgery
时间窗: after the study is completed, up to 14 months
the proportion of patients with successful operation in all participating patients in the experimental or control group
次要结局
- operation time(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)
- blood loss(after the procedure is completed, all data will be collected within 14 months)
- assembly time(after the robot is assembled, all data will be collected within 14 months)
- Time to first flatus(after the intestinal function revival of the patients, all data will be collected within 14 months)
研究者
Haitao Niu, MD
Professor Haitao Niu (The department of Urology)
The Affiliated Hospital of Qingdao University