Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055430
• Other study ID #: 61177
• Status: Completed
• Phase: N/A
• First received: February 3, 2014
• Last updated: March 19, 2014
• Start date: March 2010
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Children
• Obstructive Uropathy
• Renal Insufficiency
• Ureteral Calculi
• Ureteric Stones
• Ureterolithiasis

Intervention

Procedure:
• percutaneous nephrostomy insertion
The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.
• bilateral double J ureteric stent
The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.
• Definitive stone management
(shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones.

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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