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

NCT ID: NCT03986398

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-14
• Study Completion Date: 2020-02-09

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prophylactic efficacy of Urell®

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

Group Type: EXPERIMENTAL

Infection prophylaxis

Intervention Type: OTHER

Infection prophylaxis with Urell®, cranberry fruit juice extract (vaccinium macrocarpon)

Interventions

Infection prophylaxis

Infection prophylaxis with Urell®, cranberry fruit juice extract (vaccinium macrocarpon)

Intervention Type: OTHER

Eligibility Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martine Butreau

Role: PRINCIPAL_INVESTIGATOR

Urology department

Locations

Hôpital Foch

Suresnes, , France

Countries

France

Other Identifiers

2018045

Identifier Type: -

Identifier Source: org_study_id