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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.
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
Methods
Sample size As no available data to show the difference of urine composition prior or after surgery, the study will enroll 100 participants first to get preliminary data. Then the final sample size will be determined by the preliminary data.
Statistical Analysis: Comparisons of the urine compositions before and after stone removal will be performed using the Student's t-test for continuous variables and chi-squared for categorical variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experiment group | All eligible patients administered for active stone removal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24-h urine collection | Other | Collecting 24-h urine prior and after stone removal surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine pH Change | pH values will be determined with a glass electrode in a calibrated pH meter | Change from baseline urine pH at 4 weeks after proven stone free status |
| 24-h Urine oxalate excretion change | Urine oxalate will be measured using ion exchange chromatography | Change from baseline 24-h urine oxalate excretion at 4 weeks after proven stone free status |
| 24-h Urine citrate excretion change | Urine citrate will be measured using ion exchange chromatography | Change from baseline 24-h urine citrate excretion at 4 weeks after proven stone free status |
| 24-h Urine calcium excretion change | Urine calcium will be measured by Unicel DxC 600 synchronic biochemical detecting system. | Change from baseline 24-h urine calcium excretion at 4 weeks after proven stone free status |
| 24-h Urine phosphate excretion change | Urine phosphate will be measured by Unicel DxC 600 synchronic biochemical detecting system. | Change from baseline 24-h urine phosphate excretion at 4 weeks after proven stone free status |
| 24-h Urine sodium excretion change | Urine sodium will be measured by Unicel DxC 600 synchronic biochemical detecting system. | Change from baseline 24-h urine sodium excretion at 4 weeks after proven stone free status |
| 24-h Urine potassium excretion change |
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Inclusion Criteria:
Exclusion Criteria:
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Urolithiasis patients administered for active stone removal
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guohua Zeng, M.D. | Contact | +8613802916676 | gzgyzgh@vip.sina.com | |
| Wei Zhu, M.D. | Contact | doczw1989@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510230 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36779823 | Derived | Zhu W, Zhang X, Lu S, Ozsoy M, Zhou Z, Huang Z, Ai G, Zeng G. Comparison of 24-hour urine composition prior to and after stone removal in nephrolithiasis: a prospective observational study. Minerva Urol Nephrol. 2024 Jun;76(3):351-356. doi: 10.23736/S2724-6051.22.05164-3. Epub 2023 Feb 13. |
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D059349 | Urine Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Urine potassium will be measured by Unicel DxC 600 synchronic biochemical detecting system. |
| Change from baseline 24-h urine potassium excretion at 4 weeks after proven stone free status |
| 24-h Urine chloride excretion change | Urine chloride will be measured by Unicel DxC 600 synchronic biochemical detecting system. | Change from baseline 24-h urine chloride excretion at 4 weeks after proven stone free status |
| 24-h Urine creatinine excretion change | Urine creatinine will be measured by Unicel DxC 600 synchronic biochemical detecting system. | Change from baseline 24-h urine creatinine excretion at 4 weeks after proven stone free status |
| 24-h Urine uric acid excretion change | Urine uric acid will be measured using Beckman coulter AU680 automatic biochemistry analyzer. | Change from baseline 24-h urine uric acid excretion at 4 weeks after proven stone free status |
| 24-h Urine magnesium excretion change | Urine magnesium will be measured using Beckman coulter AU680 automatic biochemistry analyzer. | Change from baseline 24-h urine magnesium excretion at 4 weeks after proven stone free status |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |