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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

Ultrasonographic Versus Renographic Parameters in Prediction of Early Success After Pyeloplasty in Children

Clinicaltrials.gov identifier NCT03939091

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted May 6, 2019

Study Description

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.

  • Condition or Disease:Pyeloplasty
    Renogram
    Ultrasonography
    Pediatrics
  • Intervention/Treatment: Diagnostic Test: Ultrasonography
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • Official Title: Ultrasonographic Versus Renographic Parameters in Prediction of Early Success After Pyeloplasty in Children. A Prospective Study.
  • Actual Study Start Date: January 2018
  • Estimated Primary Completion Date: June 2020
  • Estimated Study Completion Date: June 2020
Arms and interventions
Arm Intervention/treatment
Other: Ultrasonography
Renal Ultrasonography
Diagnostic Test: Ultrasonography
Renal Ultrasonography
Outcome Measures
  • Primary Outcome Measures: 1. evaluate predictive value of ultrasonographic parameters for early detection of recurrent obstruction [ Time Frame: 30 months ]
    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
  • 2. evaluate predictive value of ultrasonographic parameters for early detection of decrease renal function [ Time Frame: 30 months ]
    assessed by Diuretic scintigraphy differential renal function (DRF) measured in millilitres/minute
Eligibility Criteria
  • Ages Eligible for Study: 6 to 14 Months (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- patients who will be scedueled for pyeloplasty

Exclusion Criteria:

- bilateral pathology

- Pelvi-ureteric junction obstruction (PUJO) in a solitary kidney

- other associated anomalies

Contacts and Locations
Contacts
Locations

Egypt, Outside U.S./Canada
Urology and nephrology center
Mansoura

Sponsors and Collaborators

Mansoura University

More Information
  • Responsible Party: Mansoura University
  • ClinicalTrials.gov Identifier: NCT03939091 History of Changes
  • Other Study ID Numbers: Renogram.US.Pyeloplasty
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: May 6, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Mansoura University: Ultrasonography
    Pyeloplasty
    Renogram
    Follow up