NCT05397821

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
398

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

May 25, 2022

Last Update Submit

December 3, 2023

Conditions

Kidney Transplant; ComplicationsKidney Transplant InfectionKidney Transplant Failure and Rejection

Keywords

Kidney transplantationPediatrics

Outcome Measures

Primary Outcomes (2)

  • Urinary tract infections

    Number of urinary tract infections (with fever)

    25 year

  • Ureteral obstruction

    Number of ureteral obstruction needing intervention

    25 year

Secondary Outcomes (1)

  • Graft survival

    25 years

Study Arms (2)

Radboudumc recipients

NTX performed with a refluxing technique

Procedure: UNC technique

Winsconsin recipients

NTX performed with a non-refluxing technique

Procedure: UNC technique

Interventions

UNC techniquePROCEDURE

In general, UNC techniques can be divided in being either intravesical or extravesical and refluxing or non-refluxing

Radboudumc recipientsWinsconsin recipients

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • \- Loss of follow up \< 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, 6500HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Liesbeth Lamers, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Loes Oomen, MD

CONTACT

+31613971379loes.oomen@radboudumc.nl

David Lamers, MD

CONTACT

+31654325496David.Lamers@radboudumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

June 1, 2023

Primary Completion

July 1, 2024

Study Completion

November 1, 2024

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

On request

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
25 year
Access Criteria
well written request

Locations

NL(1)