A Prospective Randomized Controlled Trial Comparing Mini Percutaneous Nephrolithotomy Vs Retrograde Intra Renal Surgery in Moderate Sized (10-20mm) Pediatric Renal Stones
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare stone free rate in mini PCNL and RIRS in management of moderate sized renal stones (10-20mm) in children at 1 month following surgery.
研究概览
简要总结
It is a prospective double blinded , parallel group , single center randomized controlled trial comparing mini pecutaneous nephrolithoyomy (Mini PCNL) vs retrograde intra renal surgery ((RIRS) in moderate sized (10-20mm) pediatric renal stones with primary objective to compare stone free rate following 1month after surgery in each arm of Mini PCNL and RIRS .The secondary objective is to compare 30 day major clavien dindo ( class I and V) complications , operative time , duration of hospital stay , emergency readmision rate till 30 day following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Parents of children who opt for either mini PCNL or RIRS b) Parents willing to give the consent to be a part of the study.
排除标准
- •a) Children who were considered for ESWL b) Active urinary tract infection (UTI) c) Renal malformation like horseshoe kidney, ectopic kidney, mal rotated kidney d) Presence of spine abnormalities like scoliosis/ kyphosis h) Presence of associated ureteric calculus i) Bilateral stone surgery is planned simultaneously e) Uncorrected coagulopathy f) Presence of ureteric stricture g) Presence of urethral stricture.
结局指标
主要结局
To compare stone free rate in mini PCNL and RIRS in management of moderate sized renal stones (10-20mm) in children at 1 month following surgery.
时间窗: 1 month after surgery
次要结局
- 1) To compare 30-day major clavien dindo (class II-V) complication rate following mini PCNL and RIRS in management of moderate sized renal stones (10-20mm) in children.(2) To compare other variables like operative time (OT) and hospital stay mini PCNL and RIRS in management of moderate sized renal stones (10-20mm) in children.)
研究者
Arshad Khan
PGIMER , CHANDIGARH