Migration of Intraureteral Stents Compared to Conventional Double-J Stents.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Stent migration
研究概览
简要总结
The purpose of this study is to determine if stents placed with only one loop in the kidney move more than stents placed with a loop in both the kidney and a bladder. Participants in this study will undergo placement of a stent into the ureter that drains urine from the kidney into the bladder. The stent will be placed in 1 of 2 ways: either with only a loop of the stent is left in the kidney or in the regular manner where a loop of the stent is left in both the kidney and in the bladder. The position of the stent will be measured at the time of placement. When the stent is removed, the position of the stent will be measured prior to pulling the stent.
详细描述
The ureteral stent is one of the most extensively used tools in the field of urology. They are used for aiding post-operative healing of the ureter, visualizing the ureteral during procedures, and alleviating ureteral obstruction (eg. nephrolithiasis). Double-J stents, which are secured by loops in both the renal pelvis and the bladder, have become most urologists' go-to choice for ureteral stents since they were introduced in the 1970s. Unfortunately, it has been shown that 80-90% of patients with ureteral stents have urinary complaints following stent placement.
Interestingly, a recent study suggested utility of intraureteral stents. These stents have one loop in the renal pelvis while their distal end is positioned proximal to the ureteral orifice. The above-mentioned study showed that patients with intraureteral stents had less discomfort as opposed to the those that had double-J stents.
Due to the immense number of patients that require ureteral stent placement, this improvement in comfort is very promising for the urological field. However, no one has studied if stents placed intraureterally migrate from the time they are placed to the time they are removed. If stents migrate proximally toward the renal pelvis, it is possible that retrieval could be more difficult, and the ureteral patency established by the stent could be compromised.
The objective of this study is to determine if intraureterally placed stents migrate as compared to ureteral stents placed via the conventional method.
This study will be a prospective, randomized controlled, single-blinded trial. The subjects will include up to 140 patients (about 70 subjects per group) from ages 1-100 years old that are to undergo stent placement for nephrolithiasis, hydronephrosis, and urological cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Subjects will not be informed of which type of ureteral stent will be used.
入排标准
- 年龄范围
- 1 Year 至 100 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those undergoing ureteral stent placement for nephrolithiasis, hydronephrosis, and urological cancer.
排除标准
- 未提供
结局指标
主要结局
Stent migration
时间窗: 12 months
The distance that the stent migrates into the bladder or into the kidney.
次要结局
- Patient comfort level(12 months)
研究者
Kellen Choi
Asst Professor
University of Louisville
