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To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| percutaneous nephrostomy | Active Comparator | percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management. |
|
| Bilateral double J ureteric stents | Active Comparator | double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous nephrostomy insertion | Procedure | The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed S ElSheemy, A professor | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals | Cairo | 12222 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24698195 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
the double J arm contains 90 ureterorenal units
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | days | 1 week |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Renal and urinary disorders | febrile urinary tract infection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr Mohammed Said ElSheemy | Cairo University | 01006117755 | mohammedshemy@yahoo.com |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D001002 | Anuria |
| D014545 | Urinary Calculi |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| bilateral double J ureteric stent | Procedure | The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance. |
|
|
| Definitive stone management | Procedure | (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones. |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| creatinine | Mean | Standard Deviation | mg/dL |
|
| hydronephrosis | Hydronephrosis was graded according to the Society for Fetal Urology grading system for hydronephrosis Fernbach SK, Maizels M, Conway JJ. Ultrasound grading of hydronephrosis: introduction to the system used by the Society for Fetal Urology. PediatrRadiol 1993;23:478-80. | Number | participants |
|
| size of stone | Mean | Standard Deviation | mm |
|
| site of stone (180 ureterorenal units) | each arm contains 90 ureterorenal units in 45 participants | Number | ureterorenal units of participants |
|
| radiolucency of stones | Number | participants |
|
| 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. |
|
|
| 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 | Not Posted | 1 week |
| 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 | Not Posted | 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 | Not Posted | 1 week |
| 0 |
| 45 |
| 2 |
| 45 |
| EG001 | 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. | 0 | 45 | 1 | 45 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D052878 | Urolithiasis |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |