The Impact of Cold Ischemia on Recovery From Ischemia After Robot-assisted Partial Nephrectomy: A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Recovery from ischemia
研究概览
简要总结
To establish evidence that cold ischemia, achieved through the use of ice slush, can improve the recovery from ischemia on the operated kidney in patients undergoing robot-assisted partial nephrectomy.
详细描述
Randomly dividing the study cohorts into two groups. One group undergoing cold ischemia partial nephrectomy and the other undergoing warm ischemia partial nephrectomy. Comparing the short-term renal function recovery between the two groups.
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
- Single (Participant)
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
- •- 18 to 80 years old;
- •Intending to perform robot-assisted partial nephrectomy
排除标准
- •Anesthesiologist assessment: Patient unsuitable for general anesthesia;
- •Having severe cardiovascular and cerebrovascular diseases;
- •horseshoe kidney;
- •pregnant women
研究组 & 干预措施
Cold ischemia
During the surgical procedure, employing ice to achieve local hypothermia in the kidneys.
干预措施: Cold ischemia robot-assisted partial nephrectomy (Procedure)
Warm ischemia
Not applying local hypothermia to the kidneys during the surgical procedure
干预措施: Warm ischemia robot-assisted partial nephrectomy (Procedure)
结局指标
主要结局
Recovery from ischemia
时间窗: 1-12 months after surgery
(%GFR saved)/(%parenchymal mass preserved)
次要结局
- surgical duration(Intraoperative)
- surgical complications(1-12 months after surgery)
- The extent of decline in the long-term GFR (month13-24) on the operated kidney compared to the new baseline GFR(months 1-12).(up to 2 years after surgery)
研究者
ZHOU FANGJIAN
professor
Sun Yat-sen University