Impact on Major Urologic Complications With Prophylactic Use of Double J Catheter in Extravesical Ureteroneocystostomy in Renal Transplant Recipients
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
Double J catheter colocation in extravesical ureteroneocystostomy
干预措施: Double J stent (Device)
No double J catheter colocation
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
Clotilde Fuentes-Orozco
MD, PhD
Instituto Mexicano del Seguro Social
