Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT 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.
Study:
NCT04212403
Study Brief:
Protocol Section:
NCT04212403