Back to resultsAntibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB) (Prophylaxis001)
Primary Purpose
Urosepsis, Bladder Cancer, Prostate Hyperplasia
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Levofloxacin
Sponsored by
About this trial
This is an interventional prevention trial for Urosepsis focused on measuring TURP, TURB
Eligibility Criteria
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).
Sites / Locations
- Jessa Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Control
Treatment group
Arm Description
The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.
The treatment group receives no AMP.
Outcomes
Primary Outcome Measures
% of patients with a post-operative infection.
Urosepsis, fever (t°> 38.5) or epididymitis.
Secondary Outcome Measures
Incidence of post-operative bacteriuria.
> 100.000 bacteria/mL urine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04212403
Brief Title
Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
December 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jessa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urosepsis, Bladder Cancer, Prostate Hyperplasia, Antibiotic Resistant Strain, Antibiotic Resistant Infection, Antibiotic-associated Diarrhea, Antibiotic Toxicity
Keywords
TURP, TURB
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled trial.
Masking
Participant
Allocation
Randomized
Enrollment
1350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.
Arm Title
Treatment group
Arm Type
No Intervention
Arm Description
The treatment group receives no AMP.
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Intervention Description
The control group receives AMP.
Primary Outcome Measure Information:
Title
% of patients with a post-operative infection.
Description
Urosepsis, fever (t°> 38.5) or epididymitis.
Time Frame
From immediately post-op until at the control consultation 4 weeks after surgery.
Secondary Outcome Measure Information:
Title
Incidence of post-operative bacteriuria.
Description
> 100.000 bacteria/mL urine
Time Frame
From immediately post-op until at the control consultation 4 weeks after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koenraad van Renterghem, PhD
Organizational Affiliation
UHasselt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3050
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)
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