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Prostate biopsy performed through the perineal skin (the area between the testicles and the anus), known as a transperineal biopsy, is currently considered the standard procedure for diagnosing prostate tumors, having replaced the biopsy performed directly through the rectum. A prostate biopsy involves taking small samples of tissue from the prostate in order to confirm or rule out suspicious changes. The reason for this shift is the lower risk of infectious complications. For this type of biopsy, it has not yet been clearly established whether preventive administration of antibiotics is necessary. Existing studies indicate that the incidence of infection is similar even without antibiotic prophylaxis. The aim of the monitoring is to confirm the safety of performing transperineal prostate biopsy without the use of antibiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic prophylaxis group | Experimental | The study arm includes patients who received antibiotic prophylaxis for prostate biopsy. |
|
| NO-Antibiotic prophylaxis group | Experimental | The study arm includes patients who received no antibiotic prophylaxis for prostate biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No antibiotic prophylaxis for prostate biopsy | Diagnostic Test | The study includes patients who received antibiotic prophylaxis for prostate biopsy, compared with a second arm consisting of patients who did not receive antibiotics during the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of post-biopsy infectious complications. | At 3 weeks and at 2 months after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| F.D. Roosevelt teaching hospital | Banská Bystrica | Slovakia |
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| Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy. | Drug | Patients who received antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy. |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D019072 | Antibiotic Prophylaxis |
| ID | Term |
|---|---|
| D018890 | Chemoprevention |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011292 | Premedication |
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