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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02139059 |
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Date of registration:
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13/05/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria
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Scientific title:
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Staged Ureteroscopy After Initial Urinary Drainage Versus Direct Ureteroscopy in the Treatment of Pediatric Obstructive Calcular Anuria |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02139059 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Mohammed S ElSheemy, A professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Name:
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Mohammed S ElSheemy, A Professor |
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Address:
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Telephone:
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01006117755 |
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Email:
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mohammedshemy@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- children =12 years old presenting with Obstructive Anuria and Acute Renal Failure due
to bilateral ureteric stones suitable for ureteroscopy.
Exclusion Criteria:
- Fever, pyonephrosis or sepsis.
- unstable patients are stabilized first by dialysis.
Age minimum:
N/A
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ureteric Stones
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Acute Renal Failure
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Anuria
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Obstructive Uropathy
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Intervention(s)
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Procedure: direct ureteroscopy
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Procedure: initial urinary drainage
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Primary Outcome(s)
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stone free status
[Time Frame: 1 week]
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Return to normal creatinine
[Time Frame: 1 week]
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operative and early post operative complications
[Time Frame: 1 week]
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Secondary Outcome(s)
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period to reach stone free status bilaterally
[Time Frame: 6 months]
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ureteric stricture
[Time Frame: 6 months]
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number of times of exposure to general anesthesia
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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