Back to resultsUreteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage
Primary Purpose
Children, Obstructive Uropathy, Acute Renal Failure
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
percutaneous nephrostomy insertion
bilateral double J ureteric stent
Definitive stone management
Sponsored by
About this trial
This is an interventional treatment trial for Children focused on measuring anuria, children, nephrostomy, stents, urinary calculi
Eligibility 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).
Sites / Locations
- Cairo University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
percutaneous nephrostomy
Bilateral double J ureteric stents
Arm Description
percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.
double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02055430
Brief Title
Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage
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 Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Obstructive Uropathy, Acute Renal Failure, Ureteric Stones
Keywords
anuria, children, nephrostomy, stents, urinary calculi
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
percutaneous nephrostomy
Arm Type
Active Comparator
Arm Description
percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.
Arm Title
Bilateral double J ureteric stents
Arm Type
Active Comparator
Arm Description
double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.
Intervention Type
Procedure
Intervention Name(s)
percutaneous nephrostomy insertion
Other Intervention Name(s)
PCN insertion, nephrostomy insertion
Intervention Description
The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.
Intervention Type
Procedure
Intervention Name(s)
bilateral double J ureteric stent
Other Intervention Name(s)
JJ
Intervention Description
The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.
Intervention Type
Procedure
Intervention Name(s)
Definitive stone management
Other Intervention Name(s)
DSM
Intervention Description
(shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones.
Primary Outcome Measure Information:
Title
Period to Return to Normal Creatinine
Description
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
Time Frame
1 week
Title
Complications of Each Drainage Method
Description
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
Time Frame
1 week
Secondary Outcome Measure Information:
Title
The Number of Subsequent Interventions Needed for Clearance of Stones .
Description
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
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Factors Affecting the Outcome of Each Group (Operative Time, Safety and Efficacy)
Description
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
Time Frame
1 week
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed S ElSheemy, A professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University Hospitals
City
Cairo
ZIP/Postal Code
12222
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
24698195
Citation
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.
Results Reference
derived
Learn more about this trial
Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage
We'll reach out to this number within 24 hrs