Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of participants with postoperative complications
研究概览
简要总结
The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using two currently available platforms:
- DaVinci®;
- Hugo®.
The questions it aims to answer are:
Does the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?
Participants will be invited to join one of these two experimental group:
- surgery with the DaVinci platform;
- surgery with the Hugo platform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient aged between 18 and 90 years old;
- •patient with localized kidney tumor suitable for partial nephrectomy;
- •patient able to understand and sign the informed consent;
- •patient compliance with the follow-up program.
排除标准
- •patient who do not fall within the inclusion age range;
- •patient not suitable for partial nephrectomy;
- •patient unable to understand and sign the informed consent;
- •patient unable to follow the monitoring program;
- •patient refusal to participate to the study.
研究组 & 干预措施
DaVinci system
Robot-assisted partial nephrectomy is performed using the DaVinci platform
干预措施: DaVinci RAPN (Device)
Hugo RAS system
Robot-assisted partial nephrectomy is performed using the Hugo RAS platform
干预措施: Hugo RAS RAPN (Device)
结局指标
主要结局
Number of participants with postoperative complications
时间窗: Over the 4 days post surgery
Overall postoperative complications (% score \>0) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication
Number of participants with moderate to major postoperative complications
时间窗: Over the 4 days post surgery
Moderate to major complications (% score \>=2) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication
Number of participants with major postoperative complications
时间窗: Over the 4 days post surgery
Major complications (% score \>=3) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication
次要结局
- Number of intraoperative technical malfunctions(Intraoperative)
- Estimated Blood Loss(Intraoperative)
- Positive Surgical Margins(Up to 2 weeks postoperative (at the end of histological analysis))
- Overall duration of the surgery(Intraoperative)
- Type of intraoperative technical malfunctions(Intraoperative)
- Number of intraoperative complications(Intraoperative)
- Type of intraoperative complications(Intraoperative)
- Postoperative hospitalization(From the day after surgery up to 10 days postoperative)
- Postoperative pain(1-4 days postoperative)
- Serum Creatinine dosage for renal function assessment(1 month, 3 and 6 months follow-up)
- Estimated Glomerular Filtration Rate for renal function assessment(1 month, 3 and 6 months follow-up)
- Procedure-related costs(From surgical procedure to the end of follow-up period (6 months))
- Time taken for platform related timings(From the room setting, through the overall surgical procedure, until postoperative room restoration for each of expected 45 surgeries (through study completion: about 4 months))
研究者
Alessandro Antonelli, MD, Prof
MD, Director of Urology Unit
Azienda Ospedaliera Universitaria Integrata Verona