ChildrenNCT02055430
Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage
A study testing percutaneous nephrostomy insertion, bilateral double J ureteric stent and Definitive stone management in people with Children and Obstructive Uropathy, run by Cairo University at 1 site in Egypt.
Trial summary
To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Children, Obstructive Uropathy, Acute Renal Failure
- What is being tested?
- percutaneous nephrostomy insertion, bilateral double J ureteric stent and Definitive stone management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children ≤12 years old presenting with Obstructive Anuria and Acute Renal Failure due to bilateral ureteric stones
Who cannot join
- Patients with grade 0-1 hydronephrosis
- fever, pyonephrosis or sepsis.
- any contraindication to both methods of drainage (urinary diversion, urethral stricture or uncontrolled coagulopathy).
Trial locations and contacts
1 site in 1 country.
About this study
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
To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children
Read the 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
- Conditions
- Children, Obstructive Uropathy, Acute Renal Failure, Ureteric Stones
- Being tested
- percutaneous nephrostomy insertion, bilateral double J ureteric stent, Definitive stone management
- Keywords
- anuria, children, nephrostomy, stents, urinary calculi
- Medical subject headings
- Acute Kidney Injury, Anuria, Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous nephrostomy insertionProcedure or surgery
Also called PCN insertion, nephrostomy insertion
The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.
bilateral double J ureteric stentProcedure or surgery
Also called JJ
The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.
Definitive stone managementProcedure or surgery
Also called DSM
(shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones.
| Study group | Role | What they receive |
|---|---|---|
| percutaneous nephrostomy | Active comparator | percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management. Receives: Procedure: percutaneous nephrostomy insertion; Procedure: 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. Receives: Procedure: bilateral double J ureteric stent; Procedure: Definitive stone management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 week
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startMar 2010
- Primary completionMar 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed said elsheemy, Cairo University
- Investigators
- Mohammed S ElSheemy, A professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055430
- Sponsor's protocol ID
- 61177
- Status last verified
- Mar 2014
- First submitted
- 3 Feb 2014
- Last updated
- 23 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24698195
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02055430
- Acronym / sponsor ID
- 61177
- Conditions
- Children, Obstructive Uropathy, Acute Renal Failure, Ureteric Stones
- Keywords
- anuria, children, nephrostomy, stents, urinary calculi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Posted 23 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| percutaneous nephrostomy | Active comparator | Procedure: percutaneous nephrostomy insertion, Procedure: Definitive stone managementpercutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management. |
| Bilateral double J ureteric stents | Active comparator | Procedure: bilateral double J ureteric stent, Procedure: Definitive stone managementdouble J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children ≤12 years old presenting with Obstructive Anuria and Acute Renal Failure due to bilateral ureteric stones
Key exclusion criteria (3 listed)
- Patients with grade 0-1 hydronephrosis
- fever, pyonephrosis or sepsis.
- any contraindication to both methods of drainage (urinary diversion, urethral stricture or uncontrolled coagulopathy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous nephrostomy insertionAlso: PCN insertion, nephrostomy insertionThe 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance. | Procedure or surgery | percutaneous nephrostomy |
| bilateral double J ureteric stentAlso: JJThe 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance. | Procedure or surgery | Bilateral double J ureteric stents |
| Definitive stone managementAlso: DSM(shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones. | Procedure or surgery | Bilateral double J ureteric stents, percutaneous nephrostomy |
Primary outcome
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
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
1 secondary outcome
The Number of Subsequent Interventions Needed for Clearance of Stones .
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24698195ElSheemy 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed S ElSheemy, A professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous nephrostomy insertion, bilateral double J ureteric stent and Definitive stone management in people with Children and Obstructive Uropathy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Period to Return to Normal Creatinine (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02055430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2014.