An interventional study of Levofloxacin in Urosepsis, Bladder Cancer and Prostate Hyperplasia, sponsored by Jessa Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-24.
Sponsored by Jessa Hospital · Not applicable, Interventional, and Prevention
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 1,350 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
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Exclusion Criteria:
TURB: pre-operative catheter/DJ/nephrostomy or clinical signs of infection (fever, myctalgia).
The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.
Drug: Levofloxacin
The treatment group receives no AMP.
The control group receives AMP.
% of patients with a post-operative infection.
Urosepsis, fever (t°\> 38.5) or epididymitis.
Time frame: From immediately post-op until at the control consultation 4 weeks after surgery.
Incidence of post-operative bacteriuria.
\> 100.000 bacteria/mL urine
Time frame: From immediately post-op until at the control consultation 4 weeks after surgery.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Jessa Hospital