NCT02287987Unknown不适用
Prospective Randomized Trial Comparing Clamp Versus Clampless Robot Assisted Partial Nephrectomy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Glomerular Filtration Rate (GFR) variation
研究概览
简要总结
Prospective, randomized trial comparing surgical, functional and oncological outcomes between clamp and clamp-less robot assisted partial nephrectomy.
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
- •normal coagulation trim
- •pre operative Glomerular Filtration Rate (GFR) > 60 ml/min
- •healty contralateral kidney
- •low (4-6) or intermediate (7-10) RENAL score
- •availability of Da Vinci Robotic System
排除标准
- •altered coagulation trim
- •pre operative Glomerular Filtration Rate (GFR) < 60 ml/min
- •anatomic or functional solitary kidney
- •RENAL score >10
研究组 & 干预措施
Clamp
Active Comparator
Laparoscopic robot-assisted partial nephrectomy with clamping the renal pedicle during the resection of the tumor
干预措施: Clamp Robotic partial nephrectomy (Procedure)
Off clamp
Experimental
Laparoscopic robot-assisted partial nephrectomy without clamping the renal pedicle during the resection of the tumor
干预措施: Clampless Robotic partial nephrectomy (Procedure)
结局指标
主要结局
Glomerular Filtration Rate (GFR) variation
时间窗: 3-6 months
difference between pre and post operative Glomerular Filtration Rate (GFR)
次要结局
- Feasibility of clampless robotic partial nephrectomy(Duration of the surgical procedure)
- Morbidity of clampless robotic partial nephrectomy(90 days)
- Oncological safety of clampless robotic partial nephrectomy(15 days)
研究者
Alessandro Antonelli
Dr
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
研究点 (1)
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