Comparison Between Modified Tubeless Super-Mini Percutaneous Nephrolithotomy, Flexible Ureterorenoscopy and Shockwave Lithotripsy for Treatment of Medium-sized Renal Stones: a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Stone free rate
研究概览
简要总结
Urinary stone disease is a common urological condition that affects millions of people worldwide, often leading to significant morbidity and healthcare costs. Medium-sized renal stones, typically defined as stones measuring 1 to 2 cm in diameter, pose a particular challenge in management. These stones are large enough to potentially cause significant obstruction and symptoms, yet their size and location make selecting an optimal treatment modality crucial for achieving favorable outcomes with minimal complications.
Historically, open surgery was the primary intervention for large or complex stones. However, the advent of minimally invasive techniques has revolutionized stone management, allowing for more effective and patient-friendly approaches. Among these, Super-mini percutaneous nephrolithotomy (SMP), flexible uretero-renoscopy (F-URS), and shock wave lithotripsy (SWL) have emerged as minimally invasive modalities for managing medium-sized renal stones.
This study aims to evaluate the outcomes; safety, efficacy, and complications associated with SMP versus F-URS Versus SWL in the management of reanl stones 10-20 mm in diameter.
详细描述
- SWL All cases will be treated as day care procedures, under analgesia without any anesthesia. Dornier MedTech (Compact Delta II), an electromagnetic shock wave lithotripter will be used. Patients will be treated in supine position and the calculus will be localized by using X-ray or Ultrasound. All sessions will be performed by a single technician under the supervision of a urology consultant. Shock waves will be delivered at the rate of 60-80 per minute with a maximum of 2500 shocks per session of treatment. Session will be started with low energy waves and gradually increased according to patient tolerability. A maximum of 2 sessions spaced two weeks apart. All patients will be advised to drink lots of fluids and maintain active lifestyle and skipping exercises if possible. Prior to every sitting an X-ray KUB will be obtained to see for the state of clearance of stone.
- Tubeless Super mini-PCNL (SMP) Modified technique will be performed in prone position using 14 Fr Amplatz sheath with the use of Karl Stroz semi rigid ureteroscope, Holmium Laser. Lithotripsy will be achieved by means of Holmium laser fiber 365 um.
Ureteric catheter will be removed after 24 hours unless there is indications for JJ stent insertion ( eg. Only functioning kidney, perforation, etc) 3. F-URS A sensor guide wire was placed into the renal pelvis via rigid ureteroscope. A 11-13 Fr access sheath will be placed into the ureter, if possible. After ureteral access was obtained, a 8 Fr flexible ureteroscope will be used for the stone treatment. The stones disintegration by holmium laser fibers. At the end of the procedure, a ureteral stent (JJ stent or Ureteric catheter) will be inserted
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 (≥ 18 years old)
- •Single renal stones 10-20 mm in longest dimension
排除标准
- •Previous upper urinary tract exploration in ipsilateral side.
- •Patients with JJ stent in ipsilateral side.
- •Absolute contraindications to SWL
研究组 & 干预措施
Modified Tubeless Super-Mini Percutaneous Nephrolithotomy
干预措施: Modified Tubeless Super-Mini Percutaneous Nephrolithotomy (Procedure)
Flexible Ureterorenoscopy
干预措施: Flexible Ureterorenoscopy (Procedure)
Shockwave Lithotripsy
干预措施: Shockwave Lithotripsy (Procedure)
结局指标
主要结局
Stone free rate
时间窗: 3 months
1. SFR (by MSCT KUB) a patient is considered stone-free if the remaining fragments are less than 3 mm in size after 3 months of the procedure
次要结局
未报告次要终点
研究者
Ahmed Hamdan Gameel
Urologist
Assiut University