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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Urine Bacterial Culture performed before TransUrethral Resection of the Bladder (TURB) | Experimental |
| |
| Urine Bacterial Culture performed 4 to 10 days before TURB | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urine bacterial Culture (UC) | Diagnostic Test | Performing a systematic UC before the TURB surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During the 30 days following TURB surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with postponed TURB surgery | Between the pre-operative consultation and date of TURB surgery, up to 60 days | |
| Time to surgery (in days), defined by the number of days between the pre-operative consultation and the date of TURB surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maxime VALLEE, MD | Contact | +33 5 16 60 42 22 | maxime.vallee@chu-poitiers.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire d'Angers | Angers | 49100 | France |
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| No intervention before TURB surgery | Other | No Urine Culture before TURB Surgery |
|
| Between the pre-operative consultation and the date of TURB surgery, up to 60 days |
| The hospital length of stay | The hospital length of stay , defined by the number of days between surgery and discharge from the hospital | Between TURB surgery and day 30 after TURB surgery |
| 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 | Proportion of patients with systemic UTI among patients with hospital readmission, defined as UTI complicated by sepsis (corresponding to a qSOFA > 1) | Within 30 days following the TURB surgery |
| 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 | Time to post-TURB infection diagnosis (in days), defined by the time between TURB surgery and the infection diagnosis date (truncated at day 30) | Between the TURB surgery and the infection diagnosis date (truncated at day 30) |
| Overall survival time | Overall survival time (in days), defined by the time between TURB surgery and the date of death (censored at day 30). | Between TURB surgery and the date of death (censored at day 30) |
| Centre Hospitalier Universitaire de Grenoble Alpes | Grenoble | 38043 | France |
|
| Centre Hospitalier de Chartres - Hôpital Louis Pasteur | Le Coudray | 28630 | France |
|
| Centre Hospitalier Universitaire de Lille | Lille | 59037 | France |
|
| Hospices Civils de Lyon | Lyon | 69229 | France |
|
| Assistance Publique - Hôpitaux de Marseille - Hôpital Nord | Marseille | 13354 | France |
|
| Centre Hospitalier Intercommunal de Mont de Marsan et du Pays des Sources | Mont-de-Marsan | 40024 | France |
|
| Centre Hospitalier Universitaire de Nantes - Hotel Dieu | Nantes | 44093 | France |
|
| AP-HP - Hôpital Universitaire Pitié-Salpêtrière | Paris | 75013 | France |
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| Hôpital Bichat Claude Bernard-APHP | Paris | 75018 | France |
|
| CHU Poitiers - Service de chirurgie urologique | Poitiers | 86000 | France |
|
| Clinique la Croix du Sud | Quint-Fonsegrives | 31130 | France |
|
| Centre hospitalier universitaire de Bordeaux | Talence | 33404 | France |
|
| Centre Hospitalier Régional et Universitaire de Tours - Bretonneau | Tours | 37044 | France |
|
| Centre Hospitalier Régional et Universitaire de Nancy - Hôpitaux de Brabois | Vandœuvre-lès-Nancy | 54500 | France |
|
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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