High Pulse Power vs. Low Pulse Power Holmium: YAG Laser in Mini-Percutaneous Nephrolithotomy for Management of Renal Stones > 20 mm: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- operative time
研究概览
简要总结
The investigator will compare between holmium laser setting during miniPCNL for renal stones as regard safety & efficacy
详细描述
The first 80 consecutive Patients presented to the department of urology, Mansoura Urology and Nephrology Center and fulfilling the inclusion criteria will be included in the present study.
Preoperatively, all patients will be thoroughly evaluated by medical history and physical examination including body mass index (BMI), laboratory assessment (including urine analysis/culture, serum biochemistry, CBC, bleeding profile).
Radiological assessment will include plain X-ray Kidney-Ureter-Bladder (KUB), abdominal ultrasound and non-contrast computed tomography (NCCT).
NCCT images will be obtained from above the kidneys through the bladder base. For each renal stone, location, largest diameter, burden and density will be assessed.
Culture based antibiotic is given. Under spinal anaesthesia, the patient is initially placed in lithotomy position for retrograde ureteral catheter placement, then repositioned to prone or modified supine position for percutaneous access.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Renal Stones < 20 mm indicated for intervention (pain, infection, obstructing stone causing hydronephrosis or parenchymal affection)
- •Informed consent obtained
排除标准
- •Active urinary tract infection
- •Bleeding diathesis
- •Pregnancy
- •Anatomical anomalies impeding access e.g. ectopic malrotated kidneys, crossed fused kidneys...etc.)
研究组 & 干预措施
high power arm
will undergo miniPCNL will high power laser setting
干预措施: mini percutaneous nephrolithotomy (Procedure)
low power group
will undergo miniPCNL will low power laser setting
干预措施: mini percutaneous nephrolithotomy (Procedure)
结局指标
主要结局
operative time
时间窗: during mini-PCNL procedure (intraoperative )
time from introduction of nephroscope till nephrostomy tube fixation
次要结局
- post operative complication(2 days)
- stone free rate at 3 month(3 month)
研究者
Ahmed Elghamry
Resident in urology
Mansoura University