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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
- Number of infectious events [ Time Frame: From study treatment start until 21 days of treatment ]Number of symptomatic and non-symptomatic events
- Digestive tolerance [ Time Frame: From study treatment start until 21 days of treatment ]Assessment on the date of resumption of transit, nausea and vomiting
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
|Contact: Elisabeth Hulier-Ammar||+33 1 46 25 11 firstname.lastname@example.org|
|Suresnes, France, 92150|
|Contact: Martine Butreau +33 1 46 25 24 67 email@example.com|
|Principal Investigator:||Martine Butreau||Urology department|