TUIKIT: Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques

Sponsor

Radboud University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05397821

Collaborator

University of Wisconsin, Madison (Other)

398

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated Enrollment :

398 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

The Optimal Method for Ureter Implantation in Pediatric Kidney Transplantation

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

Urinary tract infections [25 year]
Number of urinary tract infections (with fever)
Ureteral obstruction [25 year]
Number of ureteral obstruction needing intervention

Secondary Outcome Measures

Graft survival [25 years]
Percentage of patients with a functioning graft

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Radboud University Medical Center
University of Wisconsin, Madison

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Radboud University Medical Center

ClinicalTrials.gov Identifier:

NCT05397821

Other Study ID Numbers:

112452

First Posted:

May 31, 2022

Last Update Posted:

Jun 2, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Radboud University Medical Center

Kidney transplantation

Pediatrics

Study Results

No Results Posted as of Jun 2, 2022