Comparison of stone clearance with and without Pre-procedure Double J stenting in patients undergoing Extracorporeal Shock Wave Lithotripsy for Renal and Upper Ureteric Calculi: A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Stone clearance rate: Proportion of patients with stone clearance after extracorporeal shock wave lithotripsy after max 4 sessions (cycles) of ESWL. New cycle will be repeated after 2 weeks of the previous cycle. Xray kub will be done on post procedure day 3
研究概览
简要总结
Renal calculi (kidney stones) commonly cause hematuria and flank or groin pain, and arise due to factors like urinary stasis, metabolic imbalances (e.g., hypercalciuria, hyperoxaluria), infections, genetic disorders, and dietary influences. Diagnosis typically involves imaging such as X-rays and non-contrast CT scans. Treatment options include extracorporeal shock wave lithotripsy (ESWL), which is the first-line treatment for many stones due to its non-invasive nature and low complication rate. However, ESWL may sometimes cause complications like obstruction from stone fragments, which can be mitigated by placing a double J stent—though its routine use remains controversial.The study aims to evaluate the efficacy and safety of pre-stenting in improving ESWL outcomes.
The study aims to evaluate the effectiveness of pre-procedure double J (DJ) stenting in patients undergoing extracorporeal shock wave lithotripsy (ESWL) for renal and upper ureteric stones. It compares patients with and without stenting based on three key outcomes: **Stone clearance rate,**Complication rate and Residual stone size
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18-65 year.
- •Stones considered amenable to ESWL.
- •Solitary stone Located in kidney and upper ureter Size less than or equal to 15 mm CT Hounsefield unit less 1000.
排除标准
- •Active urinary tract infection Bleeding diathesis Pregnancy and lactation Failed attempt to stenting Uncontrolled hypertension Deranged renal function.
结局指标
主要结局
Stone clearance rate: Proportion of patients with stone clearance after extracorporeal shock wave lithotripsy after max 4 sessions (cycles) of ESWL. New cycle will be repeated after 2 weeks of the previous cycle. Xray kub will be done on post procedure day 3
时间窗: Stone clearance rate: Proportion of patients with stone clearance after extracorporeal shock wave lithotripsy after max 4 sessions (cycles) of ESWL. New cycle will be repeated after 2 weeks of the previous cycle. Xray kub will be done on post procedure day 3 | Stone clearance will be considered successful if the stone is cleared completely or could be fragmented to small (less than 4mm) passable fragments.
Stone clearance will be considered successful if the stone is cleared completely or could be fragmented to small (less than 4mm) passable fragments.
时间窗: Stone clearance rate: Proportion of patients with stone clearance after extracorporeal shock wave lithotripsy after max 4 sessions (cycles) of ESWL. New cycle will be repeated after 2 weeks of the previous cycle. Xray kub will be done on post procedure day 3 | Stone clearance will be considered successful if the stone is cleared completely or could be fragmented to small (less than 4mm) passable fragments.
次要结局
- • ESWL Failure rate: ESWL failure will be labelled if(• Stone clearance is not achieved even after 4 cycles of ESWL)
研究者
Gauri H
Maulana Azad Medical College and Lok Nayak Hospital