Trial Outcomes & Findings for Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage (NCT NCT02055430)

NCT ID: NCT02055430

Last Updated: 2014-04-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

90 participants

Primary outcome timeframe

1 week

Results posted on

2014-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	45	45
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Percutaneous Nephrostomy n=45 Participants 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.	Bilateral Double J Ureteric Stents n=45 Participants 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.	Total n=90 Participants Total of all reporting groups
Age, Continuous	4.78 years STANDARD_DEVIATION 2.295 • n=5 Participants	4.07 years STANDARD_DEVIATION 2.093 • n=7 Participants	4.42 years STANDARD_DEVIATION 2.213 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	34 Participants n=7 Participants	64 Participants n=5 Participants
Region of Enrollment Egypt	45 participants n=5 Participants	45 participants n=7 Participants	90 participants n=5 Participants
creatinine	4.3 mg/dL STANDARD_DEVIATION 1.8 • n=5 Participants	4.8 mg/dL STANDARD_DEVIATION 1.9 • n=7 Participants	4.59 mg/dL STANDARD_DEVIATION 1.901 • n=5 Participants
hydronephrosis grade 2	27 participants n=5 Participants	30 participants n=7 Participants	57 participants n=5 Participants
hydronephrosis grade 3-4	18 participants n=5 Participants	15 participants n=7 Participants	33 participants n=5 Participants
size of stone	15.011 mm STANDARD_DEVIATION 4.22 • n=5 Participants	13.25 mm STANDARD_DEVIATION 5.37 • n=7 Participants	14.1 mm STANDARD_DEVIATION 5.2 • n=5 Participants
site of stone (180 ureterorenal units) upper ureter	37 ureterorenal units of participants n=5 Participants	37 ureterorenal units of participants n=7 Participants	74 ureterorenal units of participants n=5 Participants
site of stone (180 ureterorenal units) middle ureter	16 ureterorenal units of participants n=5 Participants	15 ureterorenal units of participants n=7 Participants	31 ureterorenal units of participants n=5 Participants
site of stone (180 ureterorenal units) lower ureter	37 ureterorenal units of participants n=5 Participants	38 ureterorenal units of participants n=7 Participants	75 ureterorenal units of participants n=5 Participants
radiolucency of stones patients with radiolucent stones	27 participants n=5 Participants	28 participants n=7 Participants	55 participants n=5 Participants
radiolucency of stones patients with radioopaque stones	18 participants n=5 Participants	17 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Outcome measures

Outcome measures
Measure	Percutaneous Nephrostomy n=45 Participants 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.	Bilateral Double J Ureteric Stents n=45 Participants 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.
Period to Return to Normal Creatinine	2.22 days Standard Deviation 0.765	2.18 days Standard Deviation 0.777

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

Percutaneous Nephrostomy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Bilateral Double J Ureteric Stents

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Percutaneous Nephrostomy n=45 participants at risk 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.	Bilateral Double J Ureteric Stents n=45 participants at risk 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.
Renal and urinary disorders Fever	4.4% 2/45	2.2% 1/45

Additional Information

dr Mohammed Said ElSheemy

Cairo University

Phone: 01006117755

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place