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Completed

NCT Number: NCT02055430

Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage

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

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Key information

Conditions

Children Acute Kidney Injury Acute Renal Failure Anuria Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Obstructive Uropathy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Ureteric Stones Urinary Calculi Urination Disorders Urogenital Diseases Urolithiasis Urologic Diseases

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Cairo, 12222, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

percutaneous nephrostomy insertion

Procedure

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

Other names: PCN insertion, nephrostomy insertion

bilateral double J ureteric stent

Procedure

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

Other names: JJ

Definitive stone management

Procedure

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

Other names: DSM

Primary outcomes

  1. Period to Return to Normal Creatinine

    Time frame: 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

  2. Complications of Each Drainage Method

    Time frame: 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 outcomes

  1. The Number of Subsequent Interventions Needed for Clearance of Stones .

    Time frame: 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

Other outcomes

  1. Factors Affecting the Outcome of Each Group (Operative Time, Safety and Efficacy)

    Time frame: 1 week

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 5, 2014
Registry last updated
Apr 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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