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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)
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) |
| Actual Enrollment : | 10 participants |
| Allocation: | N/A |
| 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 |
| Actual Primary Completion Date : | February 9, 2020 |
| Actual Study Completion Date : | February 9, 2020 |
| 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)
|
- 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
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| France | |
| Hôpital Foch | |
| Suresnes, France, 92150 | |
| Principal Investigator: | Martine Butreau | Urology department |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 11, 2019 | ||||
| First Posted Date ICMJE | June 14, 2019 | ||||
| Last Update Posted Date | April 8, 2020 | ||||
| Actual Study Start Date ICMJE | April 14, 2019 | ||||
| Actual Primary Completion Date | February 9, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of infectious events [ Time Frame: From study treatment start until 21 days of treatment ] Number of symptomatic and non-symptomatic events
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
Digestive tolerance [ Time Frame: From study treatment start until 21 days of treatment ] Assessment on the date of resumption of transit, nausea and vomiting
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nosocomial Infections During Total Prostatic Cystectomies (TPC) With Replacement Enterocystoplasty: Prophylactic Role of Urell®, Cranberry Fruit Juice Extract (Vaccicium Macrocarpon) | ||||
| Official Title ICMJE | Nosocomial Infections During Total Prostatic Cystectomies (TPC) With Replacement Enterocystoplasty: Prophylactic Role of Urell®, Cranberry Fruit Juice Extract (Vaccicium Macrocarpon) | ||||
| 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 Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single Group Assignment Masking: None (Open Label)Primary Purpose: Prevention |
||||
| Condition ICMJE | Bladder Cancer | ||||
| Intervention ICMJE | Other: Infection prophylaxis
Infection prophylaxis with Urell®, cranberry fruit juice extract (vaccinium macrocarpon)
|
||||
| Study Arms ICMJE | 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
Intervention: Other: Infection prophylaxis
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Actual Enrollment ICMJE |
10 | ||||
| Original Estimated Enrollment ICMJE |
20 | ||||
| Actual Study Completion Date ICMJE | February 9, 2020 | ||||
| Actual Primary Completion Date | February 9, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03986398 | ||||
| Other Study ID Numbers ICMJE | 2018045 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Hopital Foch | ||||
| Study Sponsor ICMJE | Hopital Foch | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| PRS Account | Hopital Foch | ||||
| Verification Date | April 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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