Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage

Not Applicable

Completed

• Conditions: Ureteric Stones; Children; Obstructive Uropathy; Acute Renal Failure
• Interventions: Procedure: percutaneous nephrostomy insertion; Procedure: bilateral double J ureteric stent; Procedure: Definitive stone management

• Registration Number: NCT02055430
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2010-03
• Primary Completion: 2013-03
• Study Completion: 2013-09
• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-02-03
• Results First Submitted: 2014-02-04
• Study First Posted: 2014-02-05
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-19
• Last Update Submitted: 2014-03-19
• Results First Posted: 2014-04-23
• Last Update Posted: 2014-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
percutaneous nephrostomy	percutaneous nephrostomy insertion	percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.
percutaneous nephrostomy	Definitive stone management	percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.
Bilateral double J ureteric stents	bilateral double J ureteric stent	double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.
Bilateral double J ureteric stents	Definitive stone management	double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.

Primary Outcome Measures

Name	Time	Method
Period to Return to Normal Creatinine	1 week	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
Complications of Each Drainage Method	1 week	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

Secondary Outcome Measures

Name	Time	Method
The Number of Subsequent Interventions Needed for Clearance of Stones .	6 months	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

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt