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OpenTrials
Completed

NCT Number: NCT07008131

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guadalajara, Jalisco, 44298, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Double J stent

Device

Extravesical ureteroneocystostomy with double J-catheter placement

No Double J stent

Procedure

Extravesical ureteroneocystostomy with no Double J stent colocation

Primary outcomes

  1. Major urological complications

    Time frame: From enrollment to three months

    Urinary leakage, uretheral stenosis and urinary infection

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

Impact on Major Urologic Complications With Prophylactic Use of Double J Catheter in Extravesical Ureteroneocystostomy in Renal Transplant Recipients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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