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

NCT04212403 | Completed

• 1 other identifier: JessaH_B243201733480
• Study Type: interventional
• Target: 1,350
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

TURP; TURB

Outcome Measures

Primary Outcomes (1)

• % 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 Outcomes (1)

• Incidence of post-operative bacteriuria.

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

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Drug: Levofloxacin

Treatment group

NO INTERVENTION

The treatment group receives no AMP.

Interventions

Levofloxacin DRUG

The control group receives AMP.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TURP or TURB.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Ziekenhuis

Hasselt, Limburg, 3050, Belgium

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Prostatic Hyperplasia

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Koenraad van Renterghem, PhD

  UHasselt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled trial.

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: December 27, 2019
• Study Start: September 17, 2018
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

BE (1)