NCT04404738Unknown不适用
Clinical Studies of Robotic-assisted Surgery in Urology With MicroPort® Endoscopic Instrument Control System
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 4
- 主要终点
- surgical success rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •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.
排除标准
- •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
结局指标
主要结局
surgical success rate
时间窗: 24 hours following the surgery
Surgery is completed without conversion to other operations and without a re-operation caused by intraoperative complications within 24 hours
次要结局
- the critical failure rate of the robotic system(during the surgery)
- The psychological load of the surgeon during the surgery(immediately after the surgery)
- length of hospital stay(24 hours after discharge)
- perioperative complication rate(2 weeks after operation)
- blood loss(during the surgery)
- operative time(during the surgery)
- The physiological load of the surgeon during the surgery(immediately after the surgery)
- the recoverable malfunction rate of the robotic system(during the surgery)
- Instrument performance(immediately after the surgery)
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
2 期
Efficacy Study of Robotic Surgery for Rectal CancerRectal NeoplasmNCT01591798National Cancer Center, Korea146
已完成
不适用
Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic HysterectomyMenorrhagiaPelvic PainHysterectomyNCT02118974Milton S. Hershey Medical Center144
招募中
不适用
Robotic Radical Cystectomy OutcomesMuscle-Invasive Bladder CarcinomaOncologyRecurrenceSurgeryBladder CancerNCT04900558University of Florence500
招募中
Unknown
Clinical research on robot-assisted laparoscopic surgery for stage I and II cervical cancercervical cancerJPRN-UMIN000049513Toyohashi Municipal Hospital50
招募中
Unknown
Clinical research on robot-assisted laparoscopic surgery for stage IB and II uterine cancerJPRN-UMIN000049511Toyohashi Municipal Hospital25