Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Split Renal Function
研究概览
简要总结
The purpose of this research study is to compare the effects on kidney function after performing the removal of a kidney tumor with or without clamping the blood vessels during surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 and older.
- •Patients willing and able to sign consent.
- •Patients with an organ confined renal mass planning to undergo a robotic assisted partial nephrectomy (RAPN).
- •Patient with Karnofsky Performance Status (KPS) equal to or greater than 40.
排除标准
- •Patients under
- •Patients with Karnofsky Performance Status (KPS) less than
- •Patients with non-organ confined renal masses (invading renal vein, inferior vena cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis).
- •Patients with bilateral synchronous renal masses.
- •Patients who can not discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications.
- •Patients with renal lesions determined to be too complex to perform a RAPN without clamp by the surgeon. (The renal mass may be deemed too difficult based on pre-operatively radiological findings. The surgeon's decision to exclude a mass from a robotic assisted partial nephrectomy would be based on a higher risk of positive margin or complication if a RAPN was performed.)
研究组 & 干预措施
Off-clamp partial nephrectomy
Partial nephrectomy will be performed without clamping of the renal blood vessels.
干预措施: Off-clamp partial nephrectomy (Procedure)
Traditional partial nephrectomy
Partial nephrectomy will be performed with clamping of the renal blood vessels.
结局指标
主要结局
Percent Change From Baseline in Split Renal Function
时间窗: baseline to 3 months post nephrectomy
Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy.
Percent Change From Baseline in eGFR
时间窗: baseline and 3 months post nephrectomy
Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.
次要结局
- Number of Hospital Days Post Nephrectomy.(Day of nephrectomy to day of hospital discharge.)
- Operative Time Measured in Minutes.(At the time of nephrectomy)
- Percent of Observations With Metastasis(3 years)
- Percent of Observations With Postoperative Complications.(Within 3 months post nephrectomy.)
- Percent of Observations With Positive Surgical Margins.(at the time of nephrectomy)
- Estimated Blood Loss(At the time of nephrectomy)
- Warm Ischemia Time Measured in Minutes.(At the time of nephrectomy.)
- Percent of Observations With Intra-operative Complications.(At the time of nephrectomy)