A Prospective and Randomized Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Stone Free Rate
研究概览
简要总结
Purpose:
The aim of this present study is to compare the result of fluoroscopy, ultrasonography (US) and US combined with fluoroscopy in the guidance of minimally invasive percutaneous nephrolithotomy (MPCNL).
Methods:
The investigators will enroll 450 patients who are candidates for MPCNL in our study. By simple random sampling technique, patients will be assigned to three 150-patient groups (group 1, US-guided MPCNL, group 2, fluoroscopy-guided MPCNL and group 3, US combined with fluoroscopy-guided MPCNL). In addition to approaches in guidance of MPCNL, the rest of the procedure is the same in all three groups.The end point of the study is the comparison of outcome of procedure including stone free rate, transfusion rate, operation time, access time, length of stay and complications.
详细描述
Purpose:
Recently, PCNL or MPCNL is widely used as the most popular choice to treat patients with all types of renal stones. Successful puncture to the desired renal calyx is the key step for the operation. Nowadays puncture for renal access can be achieve using not only US guidance but fluoroscopy guidance as well. However, it is clear that there is a lack of randomized controlled data comparing fluoroscopy, US and US combined with fluoroscopy in the guidance of MPCNL. Consequently, we performed this randomized controlled trial to obtain higher grade evidence.The aim of this present study is to compare the result of fluoroscopy, US and US combined with fluoroscopy in the guidance of MPCNL.
Methods:
We will enroll 450 patients who are candidates for MPCNL in our study. By simple random sampling technique, patients will be assigned to three 150-patient groups (group 1, US-guided MPCNL, group 2, fluoroscopy-guided MPCNL and group 3, US combined with fluoroscopy-guided MPCNL).
All the patients will be diagnosed definitely before operations with kidney, ureter, and bladder (KUB), intravenous pyelography (IVP), US and/or CT.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal renal function.
- •American society of Anesthesiology (ASA) score 1 and
- •Absence of congenital abnormalities.
- •Kidney stones of diameter > 2.0cm (including multiple and staghorn stones)
排除标准
- •Patients with congenital anomalies, e.g. ectopic kidney, polycystic, horseshoe, or malrotated kidney.
- •Patients who underwent transplant or urinary diversion.
- •Patients with solitary kidney.
- •Patients will be excluded from the study if they undergoing MPCNL have purulent fluid in the initial puncture.
结局指标
主要结局
Stone Free Rate
时间窗: one day after MPCNL
Stone-free status is assessed by kidneys-ureter-bladder (KUB) or/ and noncontrast CT at day 1 after MPCNL. A stone-free state is defined as no residual stones of diameter \>4 mm.
次要结局
- Change in Hemoglobin Concentration(within 24 hours after MPCNL)
- Perioperative Complications(intraoperatively or ≤ 30 days postoperatively)
- Operation Time(intraoperatively)
研究者
Guohua Zeng
Vice President of the Hospital
The First Affiliated Hospital of Guangzhou Medical University