Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB) (Prophylaxis001)

Jessa Hospital

Status: Completed

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

Treatments: Drug: Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT04212403

JessaH_B243201733480

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,350 participants in 2 patient groups

Control

Active Comparator group

Description:

The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.

Treatment:

Drug: Levofloxacin

Treatment group

No Intervention group

Description:

The treatment group receives no AMP.