Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055430
Recruitment Status : Completed
First Posted : February 5, 2014
Results First Posted : April 23, 2014
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
mohammed said elsheemy, Cairo University

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

Condition or disease Intervention/treatment Phase
Children Obstructive Uropathy Acute Renal Failure Ureteric Stones Procedure: percutaneous nephrostomy insertion Procedure: bilateral double J ureteric stent Procedure: Definitive stone management Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : September 2013

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 Name: 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: bilateral double J ureteric stent
The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.
Other Name: JJ

Procedure: Definitive stone management
(shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones.
Other Name: DSM




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055430


Locations
Layout table for location information
Egypt
Cairo University Hospitals
Cairo, Egypt, 12222
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Principal Investigator: Mohammed S ElSheemy, A professor Cairo University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: mohammed said elsheemy, Associte professor of urology, Cairo University
ClinicalTrials.gov Identifier: NCT02055430    
Other Study ID Numbers: 61177
First Posted: February 5, 2014    Key Record Dates
Results First Posted: April 23, 2014
Last Update Posted: April 23, 2014
Last Verified: March 2014
Keywords provided by mohammed said elsheemy, Cairo University:
anuria
children
nephrostomy
stents
urinary calculi
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Acute Kidney Injury
Ureteral Calculi
Ureterolithiasis
Kidney Diseases
Urologic Diseases
Calculi
Pathological Conditions, Anatomical
Ureteral Diseases
Urolithiasis
Urinary Calculi