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Brief Title: Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)
Official Title: A Prospective Study About the Safety of Omitting Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB): the prophylaxis001-trial
Study ID: NCT04212403
Brief Summary: 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: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Jessa Ziekenhuis, Hasselt, Limburg, Belgium
Name: Koenraad van Renterghem, PhD
Affiliation: UHasselt
Role: PRINCIPAL_INVESTIGATOR