Randomized Controlled Trial Comparing Relapse Rates Between Standard Ureteroscopic Removal Of Ureteral Stone And Standard Removal With Additional Ureterorenic Clearing Of Non-Symptomatic Stones In The Kidney
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 8
- 主要终点
- Relapse of stone disease on the study side
研究概览
简要总结
Patients with a ureteral or kidney stone that causes symptoms, like pain, frequently have small kidney stones that don't cause symptoms. If these small kidney stones are determined to be asymptomatic (not causing any problems or pain), then most urologists will simply remove the symptomatic ureteral stone and leave the additional stones in the kidneys. However, symptomatic kidney stones started as small stones that didn't cause symptoms. This means that the small stones remaining in the patient's kidney may cause problems later. The purpose of our research is to test if removing small stones from the kidney prevents future stone episodes.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo surgery (URS or PCNL) for a primary stone.
- •Computed tomography (CT) exam within the 90-day pre-operative period
- •Small (≤ 6mm) asymptomatic stones in visible on KUB or CT (i.e., calcium stones) in the contralateral kidney for a primary renal stone or ipsilateral kidney for primary ureteral stone.
- •Recurrent (having had previous stones) or multiple (simultaneous bilateral stones) stones
- •Able to give informed consent
- •Age 21 years or older
排除标准
- •Inability to give informed consent
- •Age less than 21 years
- •Stones not visible on KUB or CT
- •Patients with systemic disease or renal anatomical disorders (RTA, primary hyperparathyroidism, sarcoidosis, enteric hyperoxaluria, medullary sponge kidney)
- •Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could put the
- •subject at significant risk, confound the study results, or interfere significantly with the subject's
- •participation in the study.
- •Unwilling to participate.
结局指标
主要结局
Relapse of stone disease on the study side
时间窗: annually up to 5 years after stone removal surgery
1. Radiological evidence of significant growth in the size of any pre-existing stone 2. Return for stone removal surgery on the study side 3. Passage of a stone with pain symptoms on the study side resulting in an emergency department visit
次要结局
未报告次要终点