The Presence of Ureteral Calculi Upon Supine PCNL Completion: Occlusion Balloon Catheter Versus 5FR Ureteral Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Number of Participants With Ureteral Stone Fragments Identified Endoscopically
研究概览
简要总结
Occlusion Balloon catheter provides the ability to occlude the exit of the kidney pelvis during percutaneous nephrolithotomy (PCNL) and potentially prevents the migration of stone fragments into the ureter. The necessity for it might be questioned during supine PCNL due to the upward oblique position of the kidney. The objective of the study is to compare the presence of ureteral stone fragments upon completion of supine PCNL with and without using an occlusion balloon catheter (OBC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and older.
- •Diagnosed with kidney stones and scheduled for PCNL.
- •Able and willing to provide informed consent.
排除标准
- •Pregnant women
- •Urinary tract anomalies such as urinary diversion, previous ureteral reconstruction surgeries, horseshoe kidney, solitary kidney, duplicated system, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum.
- •Prone procedure
研究组 & 干预措施
Occlusion Balloon Catheter
The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
干预措施: Occlusion Balloon Catheter (Device)
5FR Ureteral Catheter
The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
干预措施: 5FR Ureteral Catheter (Device)
结局指标
主要结局
Number of Participants With Ureteral Stone Fragments Identified Endoscopically
时间窗: During procedure, up to 5 hours
Endoscopic identification of ureteral stone fragments will be used to compare rate of ureteral stone fragments upon completion of PCNL while using OBC versus 5FR-UC.
次要结局
- Length of Procedure(During procedure, up to 5 hours)
- Number of Participants With Intraoperative Complications(During procedure, up to 5 hours)
- Number of Participants With Stent Placement(during procedure, up to 5 hours)
研究者
Mantu Gupta
Chair of Urology, MSW and MSM Hospitals Professor, Icahn School of Medicine at Mount Sinai Director of Endourology, Mount Sinai Medical Center Editor-in-Chief, Videourology
Icahn School of Medicine at Mount Sinai