Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques (TUIKIT)

December 3, 2023 updated by: Radboud University Medical Center

The Optimal Method for Ureter Implantation in Pediatric Kidney Transplantation

In this study the researchers want to retrospectively compare non-refluxing ureteroneocystostomy (UNC techniques to reflux UNC techniques in paediatric kidney recipients with regard to urinary tract infections and uteral obstruction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Multi-center retrospective study and survey on clinical practice among different urologists. The researchers will retrospectively study data on patients that received their kidney graft between 1994-2018 in either Radboudumc or UW Health University Hospital in Winsconsin.

Additionally, all urologist currently employed at those hospitals will be asked to fill in a survey on preferences in UNC techniques and suture material.

Study Type

Observational

Enrollment (Estimated)

398

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric kidney recipients that were transplanted between 1994-2018 in either Radboudumc or Winconsin University

Description

Inclusion Criteria:

  • received kidney graft in the participating centres at an age <19
  • received kidney graft between 1994-2018
  • follow-up data of at least 1 year

Exclusion Criteria:

- Loss of follow up < 1 year

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radboudumc recipients
NTX performed with a refluxing technique
Procedure: UNC technique
In general, UNC techniques can be divided in being either intravesical or extravesical and refluxing or non-refluxing
Winsconsin recipients
NTX performed with a non-refluxing technique
Procedure: UNC technique
In general, UNC techniques can be divided in being either intravesical or extravesical and refluxing or non-refluxing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary tract infections
Time Frame: 25 year
Number of urinary tract infections (with fever)
25 year
Ureteral obstruction
Time Frame: 25 year
Number of ureteral obstruction needing intervention
25 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft survival
Time Frame: 25 years
Percentage of patients with a functioning graft
25 years

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Collaborators

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Liesbeth Lamers, MD, Radboud University Medical Center

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)

June 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 112452

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

On request

IPD Sharing Time Frame

25 year

IPD Sharing Access Criteria

well written request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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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