Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage

Study Overview
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Brief Summary
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To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children

Detailed Description
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To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children with obstructive calcular anuria and acute renal failure due to ureteric calculi to identify selection criteria for initial urinary drainage method to improve drainage, to decrease complications and to facilitate subsequent definitive clearance of stones as this comparison is lacking in literature

Official Title
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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

Conditions
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Children, Obstructive Uropathy, Acute Renal Failure, Ureteric Stones

Intervention / Treatment
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* Procedure: percutaneous nephrostomy insertion
* Procedure: bilateral double J ureteric stent
* Procedure: Definitive stone management


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: percutaneous nephrostomy<br>percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management. | Procedure: percutaneous nephrostomy insertion<br>* The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.<br>* Other names: nephrostomy insertion;Procedure: Definitive stone management<br>* (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones.<br>* Other names: DSM;|
| Active Comparator: Bilateral double J ureteric stents<br>double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management. | Procedure: bilateral double J ureteric stent<br>* The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.<br>* Other names: JJ;Procedure: Definitive stone management<br>* (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones.<br>* Other names: DSM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anuria, children, nephrostomy, stents, urinary calculi