Metabolic Evaluation of Urolithiasis: Comparison of 24-hour Collecting Urine Prior and After Stone Removal - a Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 24-h Urine phosphate excretion change
研究概览
简要总结
The metabolic evaluation is crucial for determining possible underlying diseases causing stone growth and to consider the lifestyle changes or medical prophylaxis needed to prevent or at least reduce stone recurrence. 24-hour urine collection is the main part of the metabolic evaluation. The time point is suggested between 3 weeks and 3 month after stone removal, but so far there are no studies comparing 24-hour urine prior and after stone removal. In this study, investigators would like to analyze parameters in the 24-hour urine prior and after complete stone removal to see whether metabolic status can be evaluated no matter stone free or not.
详细描述
Background As the metabolic evaluation is an essential part of diagnostic and recurrence prevention of urolithiasis, the current EAU Guidelines, as well as the German S2k guidelines therefore suggest 24-hour urine collection, done twice. This evaluation is crucial for determining possible underlying diseases causing stone growth and to consider the lifestyle changes or medical prophylaxis needed to prevent or at least reduce stone recurrence.
The time point is suggested between 3 weeks and 3 month after stone removal, but so far there are no studies comparing 24-hour urine prior and after stone removal. This could simplify the diagnostic and make this essential information available for more patients suffering from urolithiasis.
Hypothesis
Null hypothesis: The analyzed parameters in the 24-hour urine prior and after complete stone removal differ from each other Alternative hypothesis: The analyzed parameters in the 24-hour urine prior and after complete stone removal do not differ from each other Primary endpoint: The difference of the analyzed parameters prior and after complete stone removal
Parameters to be collected
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients 18 years or older
- •Urolithiasis (Nephrolithiasis, Ureterolithiasis)
排除标准
- •Patients under 18 years
- •Urinary tract infection (positive urine culture prior to surgery)
- •Incomplete 24h urine collection
- •Pregnancy
- •Residual stones after surgery
结局指标
主要结局
24-h Urine phosphate excretion change
时间窗: Change from baseline 24-h urine phosphate excretion at 4 weeks after proven stone free status
Urine phosphate will be measured by Unicel DxC 600 synchronic biochemical detecting system.
24-h Urine sodium excretion change
时间窗: Change from baseline 24-h urine sodium excretion at 4 weeks after proven stone free status
Urine sodium will be measured by Unicel DxC 600 synchronic biochemical detecting system.
24-h Urine potassium excretion change
时间窗: Change from baseline 24-h urine potassium excretion at 4 weeks after proven stone free status
Urine potassium will be measured by Unicel DxC 600 synchronic biochemical detecting system.
24-h Urine uric acid excretion change
时间窗: Change from baseline 24-h urine uric acid excretion at 4 weeks after proven stone free status
Urine uric acid will be measured using Beckman coulter AU680 automatic biochemistry analyzer.
24-h Urine calcium excretion change
时间窗: Change from baseline 24-h urine calcium excretion at 4 weeks after proven stone free status
Urine calcium will be measured by Unicel DxC 600 synchronic biochemical detecting system.
Urine pH Change
时间窗: Change from baseline urine pH at 4 weeks after proven stone free status
pH values will be determined with a glass electrode in a calibrated pH meter
24-h Urine oxalate excretion change
时间窗: Change from baseline 24-h urine oxalate excretion at 4 weeks after proven stone free status
Urine oxalate will be measured using ion exchange chromatography
24-h Urine citrate excretion change
时间窗: Change from baseline 24-h urine citrate excretion at 4 weeks after proven stone free status
Urine citrate will be measured using ion exchange chromatography
24-h Urine chloride excretion change
时间窗: Change from baseline 24-h urine chloride excretion at 4 weeks after proven stone free status
Urine chloride will be measured by Unicel DxC 600 synchronic biochemical detecting system.
24-h Urine magnesium excretion change
时间窗: Change from baseline 24-h urine magnesium excretion at 4 weeks after proven stone free status
Urine magnesium will be measured using Beckman coulter AU680 automatic biochemistry analyzer.
24-h Urine creatinine excretion change
时间窗: Change from baseline 24-h urine creatinine excretion at 4 weeks after proven stone free status
Urine creatinine will be measured by Unicel DxC 600 synchronic biochemical detecting system.
次要结局
未报告次要终点
研究者
Guohua Zeng
Head of the department of urology
The First Affiliated Hospital of Guangzhou Medical University