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

NCT ID: NCT04212403

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-17

Study Completion Date

2019-12-23

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled trial.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

Levofloxacin

Intervention Type DRUG

The control group receives AMP.

Treatment group

The treatment group receives no AMP.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Levofloxacin

The control group receives AMP.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Koenraad van Renterghem, PhD

Role: PRINCIPAL_INVESTIGATOR

UHasselt

Locations

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Jessa Ziekenhuis

Hasselt, Limburg, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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JessaH_B243201733480

Identifier Type: -

Identifier Source: org_study_id

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