Bladder Cancer, Transurethral Resection of the Bladder, Urinary Tract Infection Bacterial
Conditions
Keywords
Urine Culture
Brief summary
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
Detailed description
Transurethral resection of the bladder (TURB) is a routinely performed surgery in urology (65,000/y in France). Its primary indication is the management of bladder cancer for diagnostic, prognostic, and therapeutic purposes. Currently, both French and European guidelines recommend screening for asymptomatic bacteriuria (ABU) using a urine culture (UC) before TURB. If the UC is positive, antibiotic treatment must be initiated 48 hours before surgery and continued for a maximum of 7 days after the procedure. Theoretically, the purpose of preoperative ABU screening before TURB is to reduce the rate of post-operative urinary tract infections (UTIs). However, there is currently a lack of high-level studies justifying this approach, despite its being a recommended practice. The literature estimates the rate of post-TURB UTIs to be between 2% and 3.7%. In a recent French multicentre retrospective study, the rate of postoperative febrile UTI was 2.3%. This study did not find a significant association between positive pre-operative UC and a post-operative febrile UTI. Moreover, these post-TURB infections are generally of moderate severity (Grade 2 of Clavien-Dindo classification) and do not progress to sepsis. The rate of severe infections is estimated between 0.3% and 0.74%, and no study has yet demonstrated the link between the presence of a positive preoperative UC and an increased risk of postoperative infection. The causality between preoperative UC and postoperative UTIs remains unestablished. According to the TOCUS study, approximately one-third of patients exhibit ABU before undergoing urological surgery, translating to approximately 20,000 patients annually in France. Despite the relatively low rate of post-TURB UTIs and their mild severity, guidelines mandate antibiotic treatment for these patients. Antibiotic resistance is now a daily concern for clinicians and countries alike. A prominent 2014 WHO report emphasized the consequences of antibiotic resistance, including its impact on morbidity, mortality, and societal costs. The risk of entering a post-antibiotic era by 2050 could become a reality if strong measures are not taken immediately. Therefore, we propose a non- inferiority randomized controlled trial to investigate the impact of not performing pre-operative UC before TURB on the incidence of post-TURB febrile UTIs.
Interventions
DIAGNOSTIC_TESTUrine bacterial Culture (UC)
Performing a systematic UC before the TURB surgery
OTHERNo intervention before TURB surgery
No Urine Culture before TURB Surgery
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation : oral, intravaginal, transdermal; Progestogen-only hormonal contraception associated with inhibition of ovulation : oral, injectable, implantable; Intrauterine device; Intrauterine hormone-releasing system; Bilateral tubal occlusion) or permanent sterilization methods ( hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with post-TURB symptomatic febrile Urinary Tract Infection (UTI) | During the 30 days following TURB surgery. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with postponed TURB surgery | Between the pre-operative consultation and date of TURB surgery, up to 60 days | — |
| Time to surgery | Between the pre-operative consultation and the date of TURB surgery, up to 60 days | time to surgery (in days) is defined as the number of days between the pre-operative consultation and the date of TURB surgery |
| The hospital length of stay | Between TURB surgery and day 30 after TURB surgery | The hospital length of stay , defined by the number of days between surgery and discharge from the hospital |
| Proportion of patients with hospital readmission or postoperative complications | Within 30 days following the TURB surgery | — |
| Proportion of patients with hospital readmission linked to the urinary surgical procedure | Within 30 days following the TURB surgery | — |
| Proportion of patients with systemic UTI among patients with hospital readmission | Within 30 days following the TURB surgery | Systemic UTI is defined as UTI complicated by sepsis (corresponding to a qSOFA \> 1) |
| Proportion of patients with pre-operative antibiotic prescription for preoperative colonization before the TURB surgery | Between Visit 0 (pre-operative consultation) and Visit 1(TURB surgery) | — |
| Proportion of patients with post-operative antibiotic prescription | Within 30 days following the TURB surgery | — |
| Time to post-TURB infection diagnosis | Between the TURB surgery and the infection diagnosis date (truncated at day 30) | Time to post-TURB infection diagnosis (in days), defined by the time between TURB surgery and the infection diagnosis date (truncated at day 30) |
| Overall survival time | Between TURB surgery and the date of death (censored at day 30) | Overall survival time (in days), defined by the time between TURB surgery and the date of death (censored at day 30). |
Countries
France
Contacts
CONTACTMaxime VALLEE, MD
Outcome results
None listed