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A randomized trial regarding antimicrobial prophylaxis (AMP) in transurethral resection of bladder tumor (TURB)
Ist Teil von
World journal of urology, 2021-10, Vol.39 (10), p.3839-3844
Ort / Verlag
Berlin/Heidelberg: Springer Berlin Heidelberg
Erscheinungsjahr
2021
Link zum Volltext
Quelle
MEDLINE
Beschreibungen/Notizen
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 °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).
A multivariable, logistic regression was performed for AMP and post-TURB fever with covariates: 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].
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.