- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05397821
Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques (TUIKIT)
The Optimal Method for Ureter Implantation in Pediatric Kidney Transplantation
Study Overview
Status
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Loes Oomen, MD
- Phone Number: +31613971379
- Email: loes.oomen@radboudumc.nl
Study Contact Backup
- Name: David Lamers, MD
- Phone Number: +31654325496
- Email: David.Lamers@radboudumc.nl
Study Locations
-
-
-
Nijmegen, Netherlands, 6500HB
- Recruiting
- Radboud University Medical Center
-
Contact:
- Loes Oomen
- Phone Number: +31613971379
- Email: loes.oomen@radboudumc.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
|
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
|
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
Collaborators
Investigators
- Principal Investigator: Liesbeth Lamers, MD, Radboud University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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