Flexible Ureteroscopy Using a Tip-Bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for the Treatment of 2-3 cm Renal Stones: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- stone free rate
概览
简要总结
This study aims to compare the efficacy and safety of two modern, minimally invasive surgical techniques for the removal of kidney stones: Mini-Percutaneous Nephrolithotomy (Mini-PCNL) and Flexible Ureteroscopy (FURS) with Flexible and navigable suction sheath
The primary objective is to determine which procedure results in a higher stone-free rate, as measured by post-operative imaging. Secondary objectives include comparing operative time, hospitalization length andcomplication rates between the two treatment groups.
Patients with two to three centimeter kidney stones who are candidates for either procedure will be randomly assigned to undergo either Mini-PCNL or suctioning FURS. The outcomes will be critically assessed to help establish a higher level of evidence for guiding surgical management of kidney stones.
详细描述
Mini-PCNL involves creating a small tract from the skin on the back directly into the kidney, through which a miniature nephroscope is passed to visualize and remove stones. Flexible Ureteroscopy is performed by passing a thin, flexible scope through the natural urinary passage (urethra and ureter) into the kidney. The specific FURS technique in this study utilizes a specialized scope with integrated suction, which is theorized to improve stone fragment clearance.
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
- None
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
- •Adult patients aging 18 years old or more.
- •Patients with renal stones between 2-3 cm in size confirmed by CT scan.
排除标准
- •Patients with previous ureteric injury.
- •Patients with uncontrolled diabetes mellitus or hypertension.
- •Patients with uncontrolled hepatic dysfunction.
- •Patients with uremia or renal failure.
- •Pregnant patients.
- •patients with active urinary tract infection.
- •Patients with bleeding tendency or uncontrolled coagulopathy.
- •Patients with congenital anomalies as horse-shoe kidney and pelvi-ureteric junction obstruction.
结局指标
主要结局
stone free rate
时间窗: one month postoperative
The proportion of participants in each treatment arm who are completely free of any stone fragments in the treated kidney, following the initial procedure and without the need for any secondary surgical interventions. Status will be determined by a blinded central radiologist.
次要结局
- length of hospital stay(From date of surgery until date of hospital discharge for 14 days (measured in days).)
- operative time(Measured intraoperatively, from procedure start to end (in minutes).)
研究者
Mohamed M Hasab Allah
resident of urology
Ahmed Maher Teaching Hospital