Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Study About the Safety of Omitting Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB): the prophylaxis001-trial

Conditions
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Urosepsis, Bladder Cancer, Prostate Hyperplasia, Antibiotic Resistant Strain, Antibiotic Resistant Infection, Antibiotic-associated Diarrhea, Antibiotic Toxicity

Intervention / Treatment
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* Drug: Levofloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: TURP or TURB. Exclusion Criteria: TURP: pre-operative catheter/DJ/nephrostomy or > 100 white blood cells in the pre- operative urinary sample. TURB: pre-operative catheter/DJ/nephrostomy or clinical signs of infection (fever, myctalgia).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines. | Drug: Levofloxacin<br>* The control group receives AMP.<br>|
| No Intervention: Treatment group<br>The treatment group receives no AMP. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TURP, TURB