Acute Renal Failure, Children, Obstructive Uropathy, Ureteric Stones
Conditions
Keywords
anuria, children, nephrostomy, stents, urinary calculi
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
Interventions
PROCEDUREpercutaneous nephrostomy insertion
The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.
PROCEDUREbilateral double J ureteric stent
The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.
PROCEDUREDefinitive stone management
(shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Period to Return to Normal Creatinine | 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 |
| Complications of Each Drainage Method | 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
| Measure | Time frame | Description |
|---|---|---|
| The Number of Subsequent Interventions Needed for Clearance of Stones . | 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
| Measure | Time frame | Description |
|---|---|---|
| Factors Affecting the Outcome of Each Group (Operative Time, Safety and Efficacy) | 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 |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Percutaneous Nephrostomy percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.
percutaneous nephrostomy insertion: The 1st arm was drained by PCN. 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. | 45 |
| 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.
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. | 45 |
| Total | 90 |
Baseline characteristics
| Characteristic | Percutaneous Nephrostomy | Bilateral Double J Ureteric Stents | Total |
|---|---|---|---|
| Age, Continuous | 4.78 years STANDARD_DEVIATION 2.295 | 4.07 years STANDARD_DEVIATION 2.093 | 4.42 years STANDARD_DEVIATION 2.213 |
| creatinine | 4.3 mg/dL STANDARD_DEVIATION 1.8 | 4.8 mg/dL STANDARD_DEVIATION 1.9 | 4.59 mg/dL STANDARD_DEVIATION 1.901 |
| hydronephrosis grade 2 | 27 participants | 30 participants | 57 participants |
| hydronephrosis grade 3-4 | 18 participants | 15 participants | 33 participants |
| radiolucency of stones patients with radiolucent stones | 27 participants | 28 participants | 55 participants |
| radiolucency of stones patients with radioopaque stones | 18 participants | 17 participants | 35 participants |
| Region of Enrollment Egypt | 45 participants | 45 participants | 90 participants |
| Sex: Female, Male Female | 15 Participants | 11 Participants | 26 Participants |
| Sex: Female, Male Male | 30 Participants | 34 Participants | 64 Participants |
| site of stone (180 ureterorenal units) lower ureter | 37 ureterorenal units of participants | 38 ureterorenal units of participants | 75 ureterorenal units of participants |
| site of stone (180 ureterorenal units) middle ureter | 16 ureterorenal units of participants | 15 ureterorenal units of participants | 31 ureterorenal units of participants |
| site of stone (180 ureterorenal units) upper ureter | 37 ureterorenal units of participants | 37 ureterorenal units of participants | 74 ureterorenal units of participants |
| size of stone | 15.011 mm STANDARD_DEVIATION 4.22 | 13.25 mm STANDARD_DEVIATION 5.37 | 14.1 mm STANDARD_DEVIATION 5.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 45 | 1 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
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
Time frame: 1 week
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
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Percutaneous Nephrostomy | Period to Return to Normal Creatinine | 2.22 days | Standard Deviation 0.765 |
| Bilateral Double J Ureteric Stents | Period to Return to Normal Creatinine | 2.18 days | Standard Deviation 0.777 |
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
Time frame: 6 months
Other Pre-specified
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
Time frame: 1 week