A randomized trial regarding antimicrobial prophylaxis (AMP) in transurethral resection of bladder tumor (TURB)

Abstract

Purpose 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. Materials and methods A multi-centered randomized controlled trial (RCT) from 17-09-2017 to 31-12-2019 in 5 hospitals. Patients with a pre-operative 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 degrees 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) >= Delta (6% noninferiority margin). A multivariable, logistic regression was performed for AMP and post-TURB fever with covariates: tumor size and (clot-) retention. The R Project(R) 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]. Conclusion Our data suggest the safety of omitting AMP in patients undergoing TURB without an indwelling, pre-operative catheter/nephrostomy/DJ and a negative pre-operative urinary culture.