PD55-03 A RANDOMIZED TRIAL REGARDING ANTIMICROBIAL PROPHYLAXIS (AMP) IN TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURB) IN SUPPORT OF ANTIMICROBIAL STEWARDSHIP

Abstract

You have accessJournal of UrologyBladder Cancer: Invasive IV (PD55)1 Sep 2021PD55-03 A RANDOMIZED TRIAL REGARDING ANTIMICROBIAL PROPHYLAXIS (AMP) IN TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURB) IN SUPPORT OF ANTIMICROBIAL STEWARDSHIP Evert Baten, Frank van der Aa, Hans Goethuys, Koen Slabbaert, Ingrid Arijs, and Koen van Renterghem Evert BatenEvert Baten More articles by this author , Frank van der AaFrank van der Aa More articles by this author , Hans GoethuysHans Goethuys More articles by this author , Koen SlabbaertKoen Slabbaert More articles by this author , Ingrid ArijsIngrid Arijs More articles by this author , and Koen van RenterghemKoen van Renterghem More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002089.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To determine whether omitting antimicrobial prophylaxis (AMP) in TURB is safe in patients undergoing TURB without an indwelling pre-operative catheter/nephrostomy/DJ and a negative pre-operative urinary culture. METHODS: A multi-centered randomized controlled trial (RCT) from 17-09-2017 until 31-12-2019 in 5 hospitals. Patients with a pre-operative indwelling catheter/DJ-stent or nephrostomy and a positive pre-operative urinary culture (> 104 uropathogens/mL) were excluded. Post-operative fever was defined as body temperature ≥ 38.3°C. A non-inferiority design with a 6% noninferiority margin and null hypothesis (H0) that the infection risk is at least 6% higher in the experimental (E) than in the control (C) group; H0: C (AMP-group) − E (no AMP-group) ≥ Δ (6% noninferiority margin) was used. A multivariable, logistic regression was performed with co-variates; AMP, tumor size and (clot-) retention. The R Project® for statistical computing was used for statistical analysis and a p value of 0.05 was considered as statistically significant. RESULTS: 459 Patients were included and 202/459 (44.1%) received AMP vs 257/459 (55.9%) without AMP. Fever occurred in 6/202 (2.9%; 95% CI [1.2%-6.6%]) patients with AMP vs 8/257 (3.1%; 95% CI [1.5%-6.1%]) without AMP (p=0.44). Multivariable, logistic regression showed no significant harm in omitting AMP when controlled for (clot-)retention and tumor size (p=0.85) and an adjusted risk difference in developing post-TURB fever of 0.0016; 95% CI [-0.029; 0.032]. CONCLUSIONS: Our data demonstrate the safety of omitting AMP in patients undergoing TURB without an indwelling, pre-operative catheter/nephrostomy/DJ and a negative pre-operative urinary culture. Source of Funding: / © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e997-e998 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Evert Baten More articles by this author Frank van der Aa More articles by this author Hans Goethuys More articles by this author Koen Slabbaert More articles by this author Ingrid Arijs More articles by this author Koen van Renterghem More articles by this author Expand All Advertisement Loading ...