Impact of Double J Catheter in Major Urological Complications in Renal Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

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Renal transplantation is the renal replacement therapy of choice in patients with end-stage chronic kidney disease. Major urological complications such as urinary leakage, ureteral stricture and urinary tract infections are usually observed in the first three months post-transplantation and lead to higher morbidity and mortality and lower graft function.

To evaluate the use of the double J catheter on major urological complications in extravesical ureteroneocystostomy in renal recipients.

Open clinical trial. Renal transplant recipients were included, who underwent extravesical ureteroneocystostomy with trans-surgical placement of double J catheter compared to extravesical ureteroneocystostomy without trans-surgical catheter placement. The study variables were urinary leakage, ureteral stricture, urinary tract infection, surgical complications and graft function.

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Detailed Description

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Conditions

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Kidney Transplant Urinary Complications Double J Stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Double J catheter colocation

Double J catheter colocation in extravesical ureteroneocystostomy

Group Type EXPERIMENTAL

Double J stent

Intervention Type DEVICE

Extravesical ureteroneocystostomy with double J-catheter placement

No double J catheter colocation

Extravesical ureteroneocystostomy with no double J catheter colocation

Group Type ACTIVE_COMPARATOR

No Double J stent

Intervention Type PROCEDURE

Extravesical ureteroneocystostomy with no Double J stent colocation

Interventions

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Double J stent

Extravesical ureteroneocystostomy with double J-catheter placement

Intervention Type DEVICE

No Double J stent

Extravesical ureteroneocystostomy with no Double J stent colocation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* Renal transplantation candidates
* They agree to participate in the study

Exclusion Criteria

* Previous renal transplantation
* Urinary tract malformations
* Urinary reservoir carriers
* Known neurogenic disease of the urinary tract
* Cadaveric donor grafts
* Grafts with double collecting system
* Patients whose trans-surgical findings require catheter placement.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No