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

NCT07008131 | Completed

• 1 other identifier: R-2018-1001-201
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplant; Urinary Complications; Double J Stent

Keywords

Kidney Transplant; Urinary Complications; Double J stent

Outcome Measures

Primary Outcomes (1)

• Major urological complications

  Urinary leakage, uretheral stenosis and urinary infection

  From enrollment to three months

Study Arms (2)

Double J catheter colocation

EXPERIMENTAL

Double J catheter colocation in extravesical ureteroneocystostomy

Device: Double J stent

No double J catheter colocation

ACTIVE COMPARATOR

Extravesical ureteroneocystostomy with no double J catheter colocation

Procedure: No Double J stent

Interventions

Double J stent DEVICE

Extravesical ureteroneocystostomy with double J-catheter placement

Double J catheter colocation

No Double J stent PROCEDURE

Extravesical ureteroneocystostomy with no Double J stent colocation

No double J catheter colocation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Unidad de Investigación Biomédica 02, Hospital de Especialidades, Centro Médico Nacional de Occidente

Guadalajara, Jalisco, 44298, Mexico

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)