Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12222
    • Cairo University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• ElSheemy MS, Shouman AM, Shoukry AI, ElShenoufy A, Aboulela W, Daw K, Hussein AA, Morsi HA, Badawy H. Ureteric stents vs percutaneous nephrostomy for initial urinary drainage in children with obstructive anuria and acute renal failure due to ureteric calculi: a prospective, randomised study. BJU Int. 2015 Mar;115(3):473-9. doi: 10.1111/bju.12768. Epub 2014 Oct 20.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: February 3, 2014
• First Submitted That Met QC Criteria: February 3, 2014
• First Posted (Estimate): February 5, 2014

Study Record Updates

• Last Update Posted (Estimate): April 23, 2014
• Last Update Submitted That Met QC Criteria: March 19, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: children; stents; nephrostomy; urinary calculi; anuria
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Renal Insufficiency; Acute Kidney Injury; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: 61177