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

Ultrasonographic Versus Renographic Parameters in Prediction of Early Success After Pyeloplasty in Children. A Prospective Study.

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.

Study Overview

• Status: Unknown
• Conditions: Ultrasonography; Pediatrics; Pyeloplasty; Renogram
• Intervention / Treatment: Diagnostic test: Ultrasonography

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Outside U.S./Canada
    • Mansoura, Outside U.S./Canada, Egypt, 35516
      • Recruiting
      • Urology and nephrology center
      • Contact: Ahmed Shoma; Phone Number: 502202222; Email: ahmed.shoma@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ultrasonography; Renal Ultrasonography	Diagnostic test: Ultrasonography; Renal Ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasonography; Follow up; Pyeloplasty; Renogram
• Other Study ID Numbers: Renogram.US.Pyeloplasty

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No