Pd55-05 metastasis-Directed Radiation Therapy After Radical Cystectomy for Bladder Cancer

Abstract

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 preoperative indwelling catheter/DJ-stent or nephrostomy and a positive pre-operative urinary culture (> 10 4 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) À E (no AMP-group) ! D (6% noninferiority margin) was used. A multivariable, logistic regression was performed with co-variates; AMP, tumor size and (clot-) retention. The R ProjectÒ 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.