Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Reduced OR time
研究概览
简要总结
This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more.
详细描述
This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more. Additionally, we will observe the impact of these parameters on total operative time.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between the ages of 18-
- •Any gender, race or ethnicity may be included- these factors play a small, if any role on renal calculi formation and ability to withstand procedure.
- •Must be suitable for a flexible ureteroscopy as determined by the MD
- •Large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm
- •An average stone density of at least 1000 Hounsfield units.
排除标准
- •Those with a stone burden less than 10mm or more than 20mm.
- •Those with an average stone density below 1000 Hounsfield units.
- •Patients who are dependent on mandatory anticoagulation therapies and cannot stop for surgery
- •Patients that cannot undergo ureteral access sheath placement
- •Patients with abnormal anatomy such as horseshoe kidney
- •Patients with a history of:
- •Ipsilateral upper urinary tract reconstructive procedures on the side of the renal calculi
- •Ipsilateral ureteral strictures
- •Prior radiotherapy of the abdomen or pelvis
- •Neurogenic bladder
- •Spinal cord injuries
- •Those who are pregnant
- •Currently being treated for infection or cancer
结局指标
主要结局
Reduced OR time
时间窗: 2 hours
Hybrid technique will result in overall reduced OR time
Less Energy Transmission to Patient
时间窗: 2 hours
Hybrid technique will have less energy transmission to the patient
次要结局
- Stone Free(1 month after surgery)
研究者
Brenda Romeo
Research Manager for Luay Alshara
Albany Medical College