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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04212403
Other study ID # JessaH_B243201733480
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


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.
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