Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques

Recruiting

• Conditions: Kidney Transplant; Complications; Kidney Transplant Infection; Kidney Transplant Failure and Rejection
• Interventions: Procedure: UNC technique

• Registration Number: NCT05397821
• Lead Sponsor: Radboud University Medical Center

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.

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 Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-31
• Study Start: 2023-06-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-05
• Primary Completion: 2024-07
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 398

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radboudumc recipients	UNC technique	NTX performed with a refluxing technique
Winsconsin recipients	UNC technique	NTX performed with a non-refluxing technique

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Graft survival	25 years	Percentage of patients with a functioning graft

Trial Locations

Locations (1)

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands