NCT02055430

Brief Summary

To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

April 23, 2014

Completed
Last Updated

April 23, 2014

Status Verified

March 1, 2014

Enrollment Period

3 years

First QC Date

February 3, 2014

Results QC Date

February 4, 2014

Last Update Submit

March 19, 2014

Conditions

ChildrenObstructive UropathyAcute Renal FailureUreteric Stones

Keywords

anuriachildrennephrostomystentsurinary calculi

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • The Number of Subsequent Interventions Needed for Clearance of Stones .

    6 months

Other Outcomes (1)

  • Factors Affecting the Outcome of Each Group (Operative Time, Safety and Efficacy)

    1 week

Study Arms (2)

percutaneous nephrostomy

ACTIVE COMPARATOR

percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.

Procedure: percutaneous nephrostomy insertionProcedure: 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.

Procedure: bilateral double J ureteric stentProcedure: Definitive stone management

Interventions

percutaneous nephrostomy insertionPROCEDURE

The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.

Also known as: PCN insertion, nephrostomy insertion
percutaneous nephrostomy
bilateral double J ureteric stentPROCEDURE

The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.

Also known as: JJ
Bilateral double J ureteric stents
Definitive stone managementPROCEDURE

(shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones.

Also known as: DSM
Bilateral double J ureteric stentspercutaneous nephrostomy

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children ≤12 years old presenting with Obstructive Anuria and Acute Renal Failure due to bilateral ureteric stones

You may not qualify if:

  • Patients with grade 0-1 hydronephrosis
  • fever, pyonephrosis or sepsis.
  • any contraindication to both methods of drainage (urinary diversion, urethral stricture or uncontrolled coagulopathy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, 12222, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 24698195DERIVED

MeSH Terms

Conditions

Acute Kidney InjuryAnuriaUrinary Calculi

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrination DisordersUrolithiasisCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
dr Mohammed Said ElSheemy
Organization
Cairo University
mohammedshemy@yahoo.com
01006117755

Study Officials

  • Mohammed S ElSheemy, A professor

    Cairo University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associte professor of urology

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 5, 2014

Study Start

March 1, 2010

Primary Completion

March 1, 2013

Study Completion

September 1, 2013

Last Updated

April 23, 2014

Results First Posted

April 23, 2014

Record last verified: 2014-03

Locations

EG(1)