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To investigate the use of antibiotic prophylaxis in patients undergoing TURP and TURB. The investigators set up a prospective, randomized controlled trial in which (after exclusion of risk factors) patients will be randomized in receiving levofloxacin (Tavanic) orally or no antibiotics. The exclusion criteria for TURP are a pre-operative transurethral catheter or > 100 urinary white blood cells in the pre-operative urine sample. The exclusion criteria for TURB are a pre-op catheter or clinical signs of infection.
Main objective:
To investigate the safety of omitting antibiotic prophylaxis in TURP (transurethral resection of the prostate) and TURB (transurethral bladder tumour resection) in patients without a pre-operative catheter or > 100 WBC in the pre-operative urinary sample (TURP) or clinical signs of urinary infection (TURB).
Secondary objective:
To investigate post-operative bacteriuria after TURB and TURP in our population.
Principal inclusion criterium:
Patients undergoing TURP or TURB.
Primary exclusion criterium:
TURP: pre-operative catheter or > 100 white blood cells in the pre- operative urinary sample.
TURB: pre-operative catheter or clinical signs of infection (fever, nyctalgia).
Primary endpoint:
Post-operative infection.
Secondary endpoint:
Post-operative bacteriuria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines. |
|
| Treatment group | No Intervention | The treatment group receives no AMP. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levofloxacin | Drug | The control group receives AMP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of patients with a post-operative infection. | Urosepsis, fever (t°> 38.5) or epididymitis. | From immediately post-op until at the control consultation 4 weeks after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-operative bacteriuria. | > 100.000 bacteria/mL urine | From immediately post-op until at the control consultation 4 weeks after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
TURB: pre-operative catheter/DJ/nephrostomy or clinical signs of infection (fever, myctalgia).
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| Name | Affiliation | Role |
|---|---|---|
| Koenraad van Renterghem, PhD | UHasselt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Ziekenhuis | Hasselt | Limburg | 3050 | Belgium |
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Randomized, controlled trial.
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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