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

Instituto Mexicano del Seguro Social

Status: Completed

Conditions: Kidney Transplant; Urinary Complications; Double J Stent

Treatments: Procedure: No Double J stent; Device: Double J stent

Study type: Interventional

Funder types: Other

Identifiers

NCT07008131

R-2018-1001-201

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Double J catheter colocation

Experimental group

Description:

Double J catheter colocation in extravesical ureteroneocystostomy

Treatment:

Device: Double J stent

No double J catheter colocation

Active Comparator group

Description:

Extravesical ureteroneocystostomy with no double J catheter colocation

Treatment:

Procedure: No Double J stent