Prone Flexed Position in Percutanous Nephrolithotomy in Comparsion With Standard Prone Position. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- position complications
研究概览
简要总结
prone flexed position in percutanous nephrolithotomy in comparsion with standard prone position. A randomized controlled trial.
详细描述
Patients meeting the inclusion criteria will be randomly allocated to 2 groups:
- 1st group will undergo prone-flexed PCNL.
- 2nd group will undergo prone PCNL.
III. Recruitment of participants Patients appointed for an outpatient diagnostic cystoscopy will be reviewed for the inclusion and exclusion criteria. Legible patients will be asked to participate in the study and to sign the informed consent form.
IV. Randomisation Randomization will be performed using computer generated random tables using stratified blocked randomization in 1:1 ratio.
V. Study procedure Preoperative evaluations included
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 (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Large renal or upper ureteral calculi or both,
排除标准
- •(1) Age <18 years or Pregnancy (2) Ureter pelvic junction obstruction (3) Bilateral simultaneous PCNL (4) Need for 3 percutaneous tracts intraoperative (5) Morbid obesity (BMI >40) (6) Non opaque renal stones. (7)Refuse to complete study requirements (8)Untreated UTI (9)Atypical bowel interposition by CT (10)Tumour in the presumptive access tract area or Potential malignant kidney tumour
研究组 & 干预措施
prone flexed
prone flexed PCNL position
干预措施: Percutanous nephrolithotomy (PCNL) (Procedure)
prone
prone position PCNL
干预措施: Percutanous nephrolithotomy (PCNL) (Procedure)
结局指标
主要结局
position complications
时间窗: end of the study
Comparing the prone with the prone-flexed position for PCNL reporting complications using the Clavien-Dindo system
次要结局
- stone score system(end of the study)
- stone characteristics(end of the study)
- hemostatic measures(end of the study)
- stone volume(end of the study)
研究者
Diaa Eldin Taha Ramadan Mohamed
Lecturer of urology
Kafrelsheikh University