Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage

N/ACompletedNCT02055430

Cairo University90 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Children Obstructive Uropathy Acute Renal Failure Ureteric Stones

Interventions

percutaneous nephrostomy insertionPROCEDURE

The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.

bilateral double J ureteric stentPROCEDURE

The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.

Definitive stone managementPROCEDURE

(shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones.

Eligibility

Sex: ALLMax age: 12 Years

Medical Language ↔ Plain English

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).

Locations (1)

Cairo University Hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 1 week

Secondary Outcomes

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

Time frame: 6 months

Data from ClinicalTrials.gov

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