Comparative efficacy of suction versus conventional ureteral access sheath in achieving stone free status in retrograde intrarenal surgery: A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- to compare stone free rate between use of conventional and suction ureteric access sheath
研究概览
简要总结
Retrograde Intrarenal Surgery (RIRS) is first-line surgical treatment with good stone-free rate (SFR) for renal stones ≤20mm. Newer suction ureteral access sheath has been reported to have additional advantage of improved SFR with decreased complications as compared to conventional RIRS. This study aims to identify if suction RIRS is safe and efficacious in the treatment of nephrolithiasis.
This is a hospital based comparative study. All the patients undergoing RIRS at department of urology and kidney transplant surgery will be eligible for study. Patients will be divided into suction and conventional RIRS by simple random sampling and comparison of various intraoperative and post-operative parameters will be done to assess the safety and efficacy of suction RIRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients with symptomatic renal stones undergoing retrograde intrarenal surgery (RIRS) with renal stone less than 2cm in any location.
排除标准
- •i)Age less than 18yrs ii)Congenital anomalous kidney (Horseshoe kidney, Ectopic kidney, Crossed fused renal ectopia) iii)History of previous ureteric injury and ureteric reconstruction or known ureteric anomalies (Duplex collecting system) iv)Undergoing endoscopic combined intra renal surgery v)Need for conversion to PCNL intra-operatively vi)Bilateral same sitting RIRS vii)Previous ureteric injury or known ureteric anomalies or past ureteric reconstruction viii)Patients with known chronic renal failure on renal replacement therapy ix)Need to abandon surgery intra-operatively due to non-technical reasons.
结局指标
主要结局
to compare stone free rate between use of conventional and suction ureteric access sheath
时间窗: 3 months
次要结局
- to compare complications(2 weeks)
- to compare need of re-intervention(1 month)
- to compare operative time(1 day)
- to compare stone free status(1 day)
研究者
Dr Robal Lacoul
Maharajgunj Medical Campus, Institute of Medicine, Tribhuvan University