Comparitive study of Double J stent versus externalized ureteral catheter placement in URSL ( ureteroscopic lithotripsy )
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- 1. Pain assessment using VAS after EUC placement and DJ stent placement.
研究概览
简要总结
AIM :
TO INVESTIGATE THE OUTCOMES OF SHORT TERM PLACEMENT OF A EUC IN COMPARISION TO ROUTINE PLACEMENT OF A DJ STENT AFTER URSL SURGERY.
RESEACH QUESTION :
CAN USE OF EXTERNAL URETERAL CATHETER ( EUC ) DECREASE STENT RRLATED SYMPTOMS CAUSED AFTER PLACEMENT OF A DJ STENT ?
HYPOTHESIS :
USE OF EXTERNAL URETERAL CATHETER ( EUC ) GIVES LESS STENT RELATED SYMPTOMS AS COMPARED TO DJ STENT PLACEMENT AND ALSO HAS LESS PAIN IN PATIENTS UNDERGOING URSL.
PRIMARY OBJECTIVE :
PAIN ASSESSMENT USING VAS AFTER EUC PLACEMENT AND DJ STENT PLACEMENT
SECONDARY OBJECTIVE :
QOL ASSESSMENT USING USSQ FOR EVALUATING STENT RELATED SYMPTOMS THAT AFFECT QOL.
TO COMPARE COMPLICATION RATES IN EUC PLACEMENT VS DJ STENT PLACEMENT AFTER URSL SURGERY.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing URSL greater than 18 years of age.
- •Patients with normal anatomy of Upper Urinary Tract.
- •Patients with ureteric stones less than 2 cm.
排除标准
- •Patients with Duplication anomalies of the Upper Urinary Tract.
- •Patients with UTI/ Urosepsis.
- •Patients with impacted stones in upper ureter.
- •Patients with LUTS.
- •Patients with intra-operative injuries such as mucosal flap, ureteral perforation and ureteric orifice dilatation.
结局指标
主要结局
1. Pain assessment using VAS after EUC placement and DJ stent placement.
时间窗: 1 MONTH
次要结局
- 1. QOL assessment using USSQ for evaluating stent related symptoms that affect QOL.(2. To compare the complication rates in EUC placement v/s DJ stent placement after URSL surgery.)