Laparoscopic Assisted Dismembered Pyeloplasty Versus Open Pyeloplasty in (UPJO) With Poorly Function Kidney in Pediatrics

July 18, 2023 updated by: Mohammad Daboos, Al-Azhar University
The management of kidneys with poor function less than 10% has been the subject of debate for more than a decade. Some authors have recommended nephrectomy while others favor renal salvage (pyeloplasty). the investigators reported their experience of lap assisted pyeloplasty in poorly functioning kidneys in the pediatric age group, concerning on the benefits of a minimally invasive method for repair of UPJO, in comparison with open approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Select
      • Cairo, Select, Egypt, 115678
        • Mohammad Daboos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children suffered from Uretro-pelvic junction obstruction with split renal function less than 10%

Description

Inclusion Criteria:

  • Patients with hydronephrosis diagnosed as UPJO
  • Antero-Posterior pelvic diameter more than 20 mm
  • renal function equal or less than 10%,
  • corrected by laparoscopic assisted or open pyeloplasty

Exclusion Criteria:

  • Patients with ureteral dilatation (VUR),
  • renal function more than 10%,
  • acquired and recurrent cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GroupA
Laparoscopic assisted dismembered pyeloplasty in poorly function kidney
Procedure: Dismembered Pyeloplasty
dismembered Anderson-Hynes repair was performed using 5/0 absorbable suture.
Group B
Open dismembered pyeloplasty in poorly function kidney
Procedure: Dismembered Pyeloplasty
dismembered Anderson-Hynes repair was performed using 5/0 absorbable suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal function
Time Frame: 12 months post-operative
Split renal function by Renal scan (DTPA) %
12 months post-operative
Measurments A-P renal pelvis diameter
Time Frame: 12 months
ultrasound measuerment of renal pelvis diameter by mm
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: one month
operative time by minutes
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Collaborators

University Hospital Fattouma Bourguiba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2022

Primary Completion (Actual)

March 8, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8-1-2022-000048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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