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临床试验/NCT03986398
NCT03986398终止不适用

Nosocomial Infections During Total Prostatic Cystectomies (TPC) With Replacement Enterocystoplasty: Prophylactic Role of Urell®, Cranberry Fruit Juice Extract (Vaccicium Macrocarpon)

Hopital Foch2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Hopital Foch
入组人数
10
试验地点
2
主要终点
Number of infectious events

研究概览

简要总结

Total prostatic cystectomy with enterocystoplasty is the most extensive urological surgical procedure and one with the highest complication rate, especially infectious complication. The mortality rate remains substantial (2 to 5%).

Examination of hundreds of TPCs made every year in the Urology Department of Foch Hospital, shows that nosocomial urinary infection is constant, especially when the TPC is followed by the constitution of an ileal bladder replacement.

This is due to the intervention itself and duration of postoperative urinary cathéters (ureteral and bladder). This leads to increase surveillance and antibiotic treatment, given the risks of declared infection in this context.

Detailed analysis of the last 20 TPCs with enterocystoplasty showed the presence of germs in significant numbers, in all cases.

Urell® (also sold under the Trademark Ellura®) contains a cranberry juice extract with a high content of bioactive, soluble Proanthocyanidins (PACs) . The daily dose is 36 mg total PACs measured by the DMAC/A2 method. The PACs prevent uropathogenic E.col bacteria from adhering to uroepithelial cells . Their long term use does not create any resistance of the bacteria.

The excellent prophylactic effet of Urell® had been previously observed in the same Center under different conditions.

Therefore a further demonstration was justified, of the prophylactic efficacy of Urell® in the perioperative setting of total prostato-cystectomy with substitute enterocytoplasty, where the slightest urinary infection, symptomatic or not, prolongs hospitalization and requires antibiotic treatment because of its harmful and sometimes major consequences.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • patient aged > 18 years old
  • patient with bladder cancer and total prostatic cystectomy with replacement enterocystoplasty
  • signed informed consent
  • patient with healthcare insurance

排除标准

  • patient without signed informed consent
  • patient deprived of liberty by judicial or administrative decision

结局指标

主要结局

Number of infectious events

时间窗: From study treatment start until 21 days of treatment

Number of symptomatic and non-symptomatic events

次要结局

  • Digestive tolerance(From study treatment start until 21 days of treatment)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (2)

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