Prospective randomised controlled trial to evaluate the efficay of a flexible and navigable suction ureteric access sheath on renal stone clearance compared to conventional access sheath in adult patients of renal stone disease undergoing Retrograde Intrarenal Surgery (RIRS).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
研究概览
简要总结
Renal calculi are a prevalent urological issue worldwide. Retrograde Intrarenal Surgery (RIRS) has become a primary minimally invasive treatment, especially for upper urinary tract stones.
While effective, conventional RIRS using a standard ureteric access sheath (UAS) has known limitations. Elevated intrarenal pressure during the procedure is a significant concern, increasing the risk of
postoperative fever and sepsis. Furthermore, inefficient removal of stone fragments ("dust") can lead to lower stone-free rates (SFR), potentially requiring secondary procedures. The conventional UAS
can be stiff, posing challenges in tortuous ureters and limiting the evacuation of fragments.
This study aims to address key safety and efficacy challenges in RIRS. A specially designed flexible and navigable suction ureteric access sheath (FANS-UAS) offers potential solutions by reducing
intrarenal pressure, better navigability, and better stone evacuation.
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 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients having renal stone planned for retrograde intrarenal surgery.
排除标准
- •Pregnant female Acute Infection/UTI Coagulopathy Anatomical anomaly.
研究者
DR VIPIN CHANDRA
AIIMS PATNA
