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

Not Applicable

Terminated

• Conditions: Bladder Cancer
• Interventions: Other: Infection prophylaxis

• Registration Number: NCT03986398
• Lead Sponsor: Hopital Foch

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-14
• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-14
• Primary Completion: 2020-02-09
• Study Completion: 2020-02-09
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prophylactic efficacy of Urell®	Infection prophylaxis	Prophylactic efficacy of Urell® on urinary tract infections in patients with bladder cancer and total prostatic cystectomy with replacement enterocystoplasty

Primary Outcome Measures

Name	Time	Method
Number of infectious events	From study treatment start until 21 days of treatment	Number of symptomatic and non-symptomatic events

Secondary Outcome Measures

Name	Time	Method
Digestive tolerance	From study treatment start until 21 days of treatment	Assessment on the date of resumption of transit, nausea and vomiting

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, France