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NCT05397821 Clinical Trial

Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques

Kidney Transplant; Complications Clinical Trial

— TUIKIT  

Official title:
The Optimal Method for Ureter Implantation in Pediatric Kidney Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05397821
Other study ID # 112452
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date November 2024

Study information
Verified date December 2023
Source Radboud University Medical Center
Contact Loes Oomen, MD
Phone +31613971379
Email loes.oomen@radboudumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 398
Est. completion date November 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Netherlands Radboud University Medical Center Nijmegen

Sponsors (2)
Lead Sponsor Collaborator
Radboud University Medical Center University of Wisconsin, Madison

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Urinary tract infections Number of urinary tract infections (with fever) 25 year
Primary Ureteral obstruction Number of ureteral obstruction needing intervention 25 year
Secondary Graft survival Percentage of patients with a functioning graft 25 years
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