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

Bladder Cancer Clinical Trial

— Cranberry  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03986398
• Other study ID #: 2018045
• Status: Terminated
• Phase: N/A
• Start date: April 14, 2019
• Est. completion date: February 9, 2020

Study information

• Verified date: April 2020
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 9, 2020
• Est. primary completion date: February 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Cross Infection

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of infectious events	Number of symptomatic and non-symptomatic events	From study treatment start until 21 days of treatment
Secondary	Digestive tolerance	Assessment on the date of resumption of transit, nausea and vomiting	From study treatment start until 21 days of treatment