Staged Ureteroscopy After Initial Urinary Drainage Versus Direct Ureteroscopy in the Treatment of Pediatric Obstructive Calcular Anuria
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- stone free status
Study Overview
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.
Detailed Description
To compare staged ureteroscopy following initial urinary drainage and stabilization of renal functions using percutaneous nephrostomy or double J stent versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure due to ureteric calculi in children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
stone free status
Time Frame: 1 week
success in removal of ureteric stones using ureteroscopy
Return to normal creatinine
Time Frame: 1 week
period for return to normal creatinine in both groups
operative and early post operative complications
Time Frame: 1 week
Hematuria, Extravasation (perforation), mucosal complications, stone migration, failure of ureteric access, fever
Secondary Outcomes
- ureteric stricture(6 months)
- period to reach stone free status bilaterally(6 months)
- number of times of exposure to general anesthesia(6 months)
Investigators
mohammed said elsheemy
Associte professor of urology
Cairo University