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Completed

NCT Number: NCT04212403

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

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.

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Key information

Conditions

Urosepsis Antibiotic Resistant Infection Antibiotic Resistant Strain Antibiotic Toxicity Antibiotic-associated Diarrhea Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Hyperplasia Prostatic Diseases Prostatic Hyperplasia Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Ziekenhuis

Hasselt, Limburg, 3050, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Levofloxacin

Drug

The control group receives AMP.

Primary outcomes

  1. % of patients with a post-operative infection.

    Time frame: From immediately post-op until at the control consultation 4 weeks after surgery.

    Urosepsis, fever (t°> 38.5) or epididymitis.

Secondary outcomes

  1. Incidence of post-operative bacteriuria.

    Time frame: From immediately post-op until at the control consultation 4 weeks after surgery.

    > 100.000 bacteria/mL urine

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study 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

Acronym: Prophylaxis001

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 27, 2019
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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