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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-A01317-50 | Other Identifier | ANSM |
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Indwelling urinary catheters are a primary site for nosocomial infections. The purpose of this study is to evaluate the anti-adhesive properties of Cranberry type A pro anthocyanidine gel capsules in the prevention Escherichia coli infections on indwelling urinary catheters placed in patients following pelvic surgery. The investigators primary working hypothesis is that cranberry treatment decreases E. coli colonization on indwelling urinary catheters, thus preventing nosocomial urinary infections following pelvic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cranberry | Experimental | Patients randomized to this arm will recieve one gel capsule containing cranberry PAC (36 mg of type A pro anthocyandines: Urell, Pharmatoka) per day starting at the day of the pelvic surgery (j0) until day 10 postop (j10). The gel capsule in taken orally in the morning with a large glass of water. |
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| Placebo | Placebo Comparator | The patients randomized to this arm will recieve one placebo gel capsule per day starting on the day of the pelvic surgery (j0) until the 10th day post-op (j10). The gel capsule is taken orally in the morning with a large glass of water. The placebo contains lactose and is conditioned in a manner to be identical in caliber and color with the experimental treatment gel capsules. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cranberry type A pro anthocyandines | Dietary Supplement | One gel capsule containing cranberry PAC (36 mg of type A pro anthocyandines: Urell, Pharmatoka) per day starting at the day of the pelvic surgery (j0) until day 10 postop (j10). The gel capsule in taken orally in the morning with a large glass of water |
| Measure | Description | Time Frame |
|---|---|---|
| Presence/absence of Asymptomatic bacteriuria | Presence/absence of greater than 10^5 unit forming E. coli colonies per ml of urine with absence of functional urinary infection symptoms (mictional burning, pollakiuria, dysuria, urgency, suprapubic heaviness) | 15 days post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Letouzey, MD | Centre Hospitalier Universitaire de NÄ«mes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28186383 | Result | Letouzey V, Ulrich D, Demattei C, Alonso S, Huberlant S, Lavigne JP, de Tayrac R. Cranberry capsules to prevent nosocomial urinary tract bacteriuria after pelvic surgery: a randomised controlled trial. BJOG. 2017 May;124(6):912-917. doi: 10.1111/1471-0528.14524. Epub 2017 Feb 10. | |
| 37947276 | Derived | Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7. |
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| Placebo | Dietary Supplement | One placebo gel capsule per day starting on the day of the pelvic surgery (j0) until the 10th day post-op (j10). The gel capsule is taken orally in the morning with a large glass of water. The placebo contains lactose and is conditioned in a manner to be identical in caliber and color with the experimental treatment gel capsules. |
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| 37068952 | Derived | Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6. |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D001437 | Bacteriuria |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014552 | Urinary Tract Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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