Children Clinical Trial
Official title:
Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage in Children With Obstructive Anuria and Acute Renal Failure Due to Ureteral Calculi: a Prospective, Randomized Study
Verified date | March 2014 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Higher Education |
Study type | Interventional |
To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children
Status | Completed |
Enrollment | 90 |
Est. completion date | September 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 12 Years |
Eligibility |
Inclusion Criteria: - children =12 years old presenting with Obstructive Anuria and Acute Renal Failure due to bilateral ureteric stones Exclusion Criteria: - Patients with grade 0-1 hydronephrosis - fever, pyonephrosis or sepsis. - any contraindication to both methods of drainage (urinary diversion, urethral stricture or uncontrolled coagulopathy). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University Hospitals | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Factors Affecting the Outcome of Each Group (Operative Time, Safety and Efficacy) | age, site of stones, size of stones, degree of hydronephrosis they were calculated per 45 ureterorenal units in PCN group and 90 ureterorenal units in Double J group |
1 week | Yes |
Primary | Period to Return to Normal Creatinine | period required for normalization of serum creatinine after initial urinary drainage using percutaneous nephrostomy or ureteric stent in children with obstructive calcular anuria and Acute Renal Failure serum creatinine was compared to normal values in matched healthy children |
1 week | No |
Primary | Complications of Each Drainage Method | complications of initial urinary drainage using percutaneous nephrostomy or ureteric stent in children with Obstructive Anuria and Acute Renal Failure (mucosal complications, failure of insertion, slippage, fever and infection, hematuria, leakage) complications were calculated per 45 ureterorenal units in PCN group and 90 ureterorenal units in Double J group |
1 week | Yes |
Secondary | The Number of Subsequent Interventions Needed for Clearance of Stones . | The number of subsequent interventions needed for clearance of stones after normalization of serum creatinine in relation to initial urinary drainage method using percutaneous nephrostomy or ureteric stent in children with Obstructive Anuria and Acute Renal Failure | 6 months | No |
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