Endoscopic Combined Intrarenal Surgery for Management of Large Renal Stones: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Stone Free Rate
研究概览
简要总结
currently, percutaneous nephrolithotomy (PCNL) is the standard procedure of choice for management of large renal more than 2 cm.
the pivotal step in performing PCNL is creation of proper tract. this step can be done monitored under guidance of different modalities such as fluoroscopy, ultrasonography, endoscopy or combined in ECIRS, tract creation is controlled under endoscopic vision with a flexible ureteroscope .
详细描述
Aim: compare safety and efficacy and adverse events of ECIRS in comparison of standard fluoroscopic guided PCNL.
patients & methods: Patients will randomly be divided into two equal groups:
Group A: Patient will undergo ECIRS.
Group B: Patient will undergo standard PCNL
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
- Double (Participant, Outcomes Assessor)
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
- •patients with renal stones diameter of at least 2 cm.
- •American Society of Anesthesiology score ≤ 2.
排除标准
- •patients with renal anomalies.
- •transplanted kidney.
- •uncorrected coagulopathy.
- •active infection.
研究组 & 干预措施
ECIRS-Group
干预措施: Endoscopic compbined guided PCNL (Procedure)
SPCNL-GRoup
干预措施: Standard PCNL (Procedure)
结局指标
主要结局
Stone Free Rate
时间窗: 3 months post-operative
If their is any residual stones
Stone Free Rate
时间窗: 1day after operation.
If their is any residual stones
Stone Free Rate
时间窗: 1 months post operative
If their is any residual stones
次要结局
- operative time(intra oprative)
- blood loss(pre-operative and 1 day post-oprative)
研究者
Waleed El-Shaer, MD
Associate professor
Benha University