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

Autor: K Slabbert, F. Van Der Aa, H Goethuys, Evert Baten, Ingrid Arijs, K. Van Renterghem
Rok vydání: 2021
Předmět:
Zdroj: World Journal of Urology. 39:3839-3844
ISSN: 1433-8726
0724-4983
Popis: 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. Baten, E (corresponding author), Associatie Urol Hageland, Kapellekensweg 10, Kessel Lo, Belgium ; Univ Hasselt, Martelarenlaan 45, B-3050 Hasselt, Belgium. Evert.baten@gmail.com
Databáze: OpenAIRE
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