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

Not Applicable

Completed

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

• Registration Number: NCT04212403
• Lead Sponsor: Jessa Hospital

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 Timeline

• Study Start: 2018-09-17
• Study First Submitted: 2019-08-06
• Primary Completion: 2019-12-23
• Study Completion: 2019-12-23
• Study First Submitted QC: 2019-12-23
• Study First Posted: 2019-12-27
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1350

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Levofloxacin	The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.

Primary Outcome Measures

Name	Time	Method
% of patients with a post-operative infection.	From immediately post-op until at the control consultation 4 weeks after surgery.	Urosepsis, fever (t°\> 38.5) or epididymitis.

Secondary Outcome Measures

Name	Time	Method
Incidence of post-operative bacteriuria.	From immediately post-op until at the control consultation 4 weeks after surgery.	\> 100.000 bacteria/mL urine

Trial Locations

Locations (1)

Jessa Ziekenhuis; 🇧🇪 Hasselt, Limburg, Belgium