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Relevance of the Urine Bacterial Culture Performed Before TransUrethral Resection of the Bladder for Post-operative Febrile Urinary Tract Infections Prevention: a Non-inferiority Randomized Controlled Trial

ConditionsBladder CancerTransurethral Resection of the BladderUrinary Tract Infection Bacterial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital

About this trial

The main objective of the study is to demonstrate that not performing a systematic UC before the TURB procedure is non-inferior to performing a systematic UC in terms of the incidence of febrile UTIs during the first 30 postoperative days

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient aged 18 or over

Scheduled for TURB surgery for a suspected or confirmed diagnosis of bladder tumor

Affiliated person or beneficiary of a social security scheme

Written informed consent obtained from the participant

Disqualifiers

Patient with active UTI

Planned combined surgery

Patient previously included in this research protocol

People benefiting from enhanced protection, namely minors, people deprived of their liberty by judicial or administrative decision, people staying in a health or social institution, adults under legal protection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Urine bacterial Culture (UC)

    Diagnostic test

    Performing a systematic UC before the TURB surgery

  • No intervention before TURB surgery

    Other intervention

    No Urine Culture before TURB Surgery

Treatment groups

2,600 Participants
are divided into 2 treatment groups
Group A: No Urine Bacterial Culture performed before TransUrethral Resection of the Bladder (TURB)Experimental treatment 1 intervention
Group B: Urine Bacterial Culture performed 4 to 10 days before TURBActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with post-TURB symptomatic febrile Urinary Tract Infection (UTI)

The diagnosis of a febrile UTI will be based on clinical, biological and microbiological criteria, as defined by Bilsen et al. based on an international expert consensus (PMID: 38458204)

Time frame
During the 30 days following TURB surgery.

Secondary outcomes

1

Proportion of patients with postponed TURB surgery

Time frame
Between the pre-operative consultation and date of TURB surgery, up to 60 days
2

Time to surgery

time to surgery (in days) is defined as the number of days between the pre-operative consultation and the date of TURB surgery

Time frame
Between the pre-operative consultation and the date of TURB surgery, up to 60 days
3

The hospital length of stay

The hospital length of stay , defined by the number of days between surgery and discharge from the hospital

Time frame
Between TURB surgery and day 30 after TURB surgery
4

Proportion of patients with hospital readmission or postoperative complications

Time frame
Within 30 days following the TURB surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Poitiers University Hospital

Lead sponsor

Source ClinicalTrials.gov
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