NCT04120805进行中（未招募）不适用
Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-Assisted Laparoscopic Partial Nephrectomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- An absolute change in hemoglobin
研究概览
简要总结
The purpose of this study is to evaluate the necessity of using hemostatic agents as a tool when performing robotic partial nephrectomy in the treatment of kidney cancer. This project asks whether patients who undergo robotic partial nephrectomy without the surgeon using hemostatic agents during the procedure will have the same, fewer, or more complications than when patients undergo this same surgery with the surgeon using hemostatic agents during the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Male and female patients aged 18 years and older.
- •Patients must have a solid or cystic renal mass suspicious for malignancy by imaging with ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI).
- •Patients must be initially scheduled RALPN as opposed to radical nephrectomy or other techniques for partial nephrectomy such as open surgery or pure laparoscopy without robot assistance.
- •Patients with bilateral kidneys or a solitary kidney, so long as these are native kidneys as opposed to a transplanted kidney.
- •Patients can have the common single renal artery and single renal vein, or they can have common variants such as two renal arteries and/or two renal veins.
排除标准
- •Patients on hemodialysis.
- •Patients who have had a renal transplantation.
- •Patients on therapeutic anticoagulation prior to surgery (example anticoagulants include: aspirin 325 mg daily, clopidogrel, warfarin, fondaparinux, dabigatran, and rivaroxaban). However, patients who take aspirin 81 mg daily as their daily regimen will be included.
- •Patients with bleeding disorders (example: hemophilia) and other documented coagulopathy (example: chronic liver disease) with INR greater than 1.0 at baseline.
- •Patients who have had a prior surgical procedure, aside from percutaneous renal biopsy, on the kidney in the current operation.
- •Patients with over 100 mL of estimated blood loss (calculated by anesthesia team using the suction canisters) prior to clamping of the renal hilum will be excluded.
研究组 & 干预措施
Group 2 (Hemostatic Agents Negative -)
Active Comparator
No Hemostatic Agent
干预措施: No Hemostatic Agent (Other)
Group 1 (Hemostatic Agents Plus +)
Experimental
干预措施: Hemostatic Agent (Device)
结局指标
主要结局
An absolute change in hemoglobin
时间窗: up to 6 months
The change in hemoglobin will be measured as the difference between the hemoglobin obtained postoperatively and the hemoglobin obtained preoperatively.
次要结局
- Total number of major bleeding complications(up to 6 months)
- Patients with a hospital stay over 30 days(up to 6 months)
- Safety monitoring parameters: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(up to 6 months)
- Operating room parameters(up to 6 months)
研究者
研究点 (1)
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