Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria
Staged Ureteroscopy After Initial Urinary Drainage Versus Direct Ureteroscopy in the Treatment of Pediatric Obstructive Calcular Anuria
1 other identifier
interventional
50
1 country
2
Brief Summary
To compare staged ureteroscopy following initial urinary drainage versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 3, 2015
February 1, 2015
1.2 years
May 13, 2014
February 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Return to normal creatinine
period for return to normal creatinine in both groups
1 week
stone free status
success in removal of ureteric stones using ureteroscopy
1 week
operative and early post operative complications
Hematuria, Extravasation (perforation), mucosal complications, stone migration, failure of ureteric access, fever
1 week
Secondary Outcomes (3)
ureteric stricture
6 months
period to reach stone free status bilaterally
6 months
number of times of exposure to general anesthesia
6 months
Study Arms (2)
initial urinary drainage
ACTIVE COMPARATORinitial urinary drainage to stabilize renal functions before ureteroscopy
direct ureteroscopy
ACTIVE COMPARATORdirect ureteroscopy without initial urinary drainage
Interventions
initial urinary drainage is done using nephrostomy or double J stent to stabilize renal functions. this is followed several days later by definitive ureteroscopy.
direct ureteroscopy is done without initial urinary drainage and before return to normal chemistry. this is followed follow-up of renal functions for several days before treatment of the contralateral side.
Eligibility Criteria
You may qualify if:
- children ≤12 years old presenting with Obstructive Anuria and Acute Renal Failure due to bilateral ureteric stones suitable for ureteroscopy.
You may not qualify if:
- Fever, pyonephrosis or sepsis.
- unstable patients are stabilized first by dialysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (2)
Cairo University Hospitals
Cairo, 12222, Egypt
Cairo University Hospitals
Cairo, 12222, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohammed S ElSheemy, A professor
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associte professor of urology
Study Record Dates
First Submitted
May 13, 2014
First Posted
May 15, 2014
Study Start
June 1, 2014
Primary Completion
August 1, 2015
Study Completion
December 1, 2015
Last Updated
February 3, 2015
Record last verified: 2015-02