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临床试验/NCT07008131
NCT07008131已完成不适用

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

Instituto Mexicano del Seguro Social1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
Major urological complications

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Double J catheter colocation

Experimental

Double J catheter colocation in extravesical ureteroneocystostomy

干预措施: Double J stent (Device)

No double J catheter colocation

Active Comparator

Extravesical ureteroneocystostomy with no double J catheter colocation

干预措施: No Double J stent (Procedure)

结局指标

主要结局

Major urological complications

时间窗: From enrollment to three months

Urinary leakage, uretheral stenosis and urinary infection

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Clotilde Fuentes-Orozco

MD, PhD

Instituto Mexicano del Seguro Social

研究点 (1)

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