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Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques (TUIKIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05397821
Recruitment Status : Recruiting
First Posted : May 31, 2022
Last Update Posted : December 5, 2023
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Kidney Transplant; Complications Kidney Transplant Infection Kidney Transplant Failure and Rejection Procedure: UNC technique

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 Design
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Study Type : Observational
Estimated Enrollment : 398 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Optimal Method for Ureter Implantation in Pediatric Kidney Transplantation
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Urinary tract infections [ Time Frame: 25 year ]
    Number of urinary tract infections (with fever)

  2. Ureteral obstruction [ Time Frame: 25 year ]
    Number of ureteral obstruction needing intervention


Secondary Outcome Measures :
  1. Graft survival [ Time Frame: 25 years ]
    Percentage of patients with a functioning graft


Eligibility Criteria
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Ages Eligible for Study:   0 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05397821


Contacts
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Contact: Loes Oomen, MD +31613971379 loes.oomen@radboudumc.nl
Contact: David Lamers, MD +31654325496 David.Lamers@radboudumc.nl

Locations
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Netherlands
Radboud University Medical Center Recruiting
Nijmegen, Netherlands, 6500HB
Contact: Loes Oomen    +31613971379    loes.oomen@radboudumc.nl   
Sponsors and Collaborators
Radboud University Medical Center
University of Wisconsin, Madison
Investigators
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Principal Investigator: Liesbeth Lamers, MD Radboud University Medical Center
More Information
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT05397821    
Other Study ID Numbers: 112452
First Posted: May 31, 2022    Key Record Dates
Last Update Posted: December 5, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: On request
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 25 year
Access Criteria: well written request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University Medical Center:
Kidney transplantation
Pediatrics