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

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ClinicalTrials.gov Identifier: NCT03986398
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Bladder Cancer Other: Infection prophylaxis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nosocomial Infections During Total Prostatic Cystectomies (TPC) With Replacement Enterocystoplasty: Prophylactic Role of Urell®, Cranberry Fruit Juice Extract (Vaccicium Macrocarpon)
Actual Study Start Date : April 14, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prophylactic efficacy of Urell®
Prophylactic efficacy of Urell® on urinary tract infections in patients with bladder cancer and total prostatic cystectomy with replacement enterocystoplasty
Other: Infection prophylaxis
Infection prophylaxis with Urell®, cranberry fruit juice extract (vaccinium macrocarpon)




Primary Outcome Measures :
  1. Number of infectious events [ Time Frame: From study treatment start until 21 days of treatment ]
    Number of symptomatic and non-symptomatic events


Secondary Outcome Measures :
  1. Digestive tolerance [ Time Frame: From study treatment start until 21 days of treatment ]
    Assessment on the date of resumption of transit, nausea and vomiting



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986398


Contacts
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Contact: Elisabeth Hulier-Ammar +33 1 46 25 11 75 drci-promotion@hopital-foch.com

Locations
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France
Hôpital Foch Recruiting
Suresnes, France, 92150
Contact: Martine Butreau    +33 1 46 25 24 67    m.butreau@hopital-foch.com   
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Martine Butreau Urology department

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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03986398     History of Changes
Other Study ID Numbers: 2018045
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cross Infection
Urinary Bladder Neoplasms
Infection
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Iatrogenic Disease
Disease Attributes
Pathologic Processes