NCT03939091

Brief Summary

To study the predictive value of ultrasonographic (USG) parameters in the form of anteroposterior diameter , calyceal dilatation , calyx-to-parenchyma ratio , renal length , renal width , pelvis-to-cortex ratio (PCR) and parenchymal thickness versus renographic parameters in the form of T1/2 , differential renal function (DRF) and Tissue tracer transit (TTT) for early detection of children at risk of recurrent obstruction post unilateral pyeloplasty.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 6, 2019

Status Verified

April 1, 2019

Enrollment Period

2.4 years

First QC Date

April 23, 2019

Last Update Submit

May 3, 2019

Conditions

PyeloplastyPediatricsRenogramUltrasonography

Keywords

UltrasonographyPyeloplastyRenogramFollow up

Outcome Measures

Primary Outcomes (2)

  • evaluate predictive value of ultrasonographic parameters for early detection of recurrent obstruction

    assessed by Diuretic scintigraphy (T1/2) as the time it takes for the activity in the kidney to decrease to 50% of its maximum value measured in minutes

    30 months

  • evaluate predictive value of ultrasonographic parameters for early detection of decrease renal function

    assessed by Diuretic scintigraphy differential renal function (DRF) measured in millilitres/minute

    30 months

Study Arms (1)

Ultrasonography

OTHER

Renal Ultrasonography

Diagnostic Test: Ultrasonography

Interventions

UltrasonographyDIAGNOSTIC_TEST

Renal Ultrasonography

Ultrasonography

Eligibility Criteria

Age6 Months - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patients who will be scedueled for pyeloplasty

You may not qualify if:

  • bilateral pathology
  • Pelvi-ureteric junction obstruction (PUJO) in a solitary kidney
  • other associated anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and nephrology center

Al Mansurah, Outside U.S./Canada, 35516, Egypt

RECRUITING

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2019

First Posted

May 6, 2019

Study Start

January 1, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

May 6, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)