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

Bladder Cancer Clinical Trial

— Prophylaxis001  

Official title:

A Prospective Study About the Safety of Omitting Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB): the prophylaxis001-trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04212403
• Other study ID #: JessaH_B243201733480
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: December 23, 2019

Study information

• Verified date: February 2020
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1350
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Antibiotic Resistant Strain
• Antibiotic Toxicity
• Antibiotic-associated Diarrhea
• Bladder Cancer
• Diarrhea
• Hyperplasia
• Prostate Hyperplasia
• Prostatic Hyperplasia
• Urinary Bladder Neoplasms
• Urosepsis

Intervention

Drug:
• Levofloxacin
The control group receives AMP.

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of patients with a post-operative infection.	Urosepsis, fever (t°> 38.5) or epididymitis.	From immediately post-op until at the control consultation 4 weeks after surgery.
Secondary	Incidence of post-operative bacteriuria.	> 100.000 bacteria/mL urine	From immediately post-op until at the control consultation 4 weeks after surgery.