Trials / Completed
CompletedNCT04212403
Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)
A Prospective Study About the Safety of Omitting Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB): the prophylaxis001-trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,350 (actual)
- Sponsor
- Jessa Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Urosepsis
- Bladder Cancer
- Prostate Hyperplasia
- Antibiotic Resistant Strain
- Antibiotic Resistant Infection
- Antibiotic-associated Diarrhea
- Antibiotic Toxicity
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levofloxacin | The control group receives AMP. |
Timeline
- Start date
- 2018-09-17
- Primary completion
- 2019-12-23
- Completion
- 2019-12-23
- First posted
- 2019-12-27
- Last updated
- 2020-02-24
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04212403. Inclusion in this directory is not an endorsement.