Belgium: Omitting antimicrobial prophylaxis is safe in patients undergoing transurethral resection of the prostate without preoperative pyuria and a preoperative indwelling catheter, according to results from a randomized trial published in The Journal of Urology.
The study was conducted by E. Baten, Associatie Urologie Hageland, Tielt-Winge, Belgium, and colleagues with an objective to determine the safety of antimicrobial prophylaxis omission in patients undergoing transurethral resection of the prostate without preoperative pyuria and a preoperative catheter in a multicenter randomized controlled trial from September 17, 2017, until December 31, 2019, in 5 hospitals.
Patients with pyuria (>100 white blood cells/ml) and a preoperative indwelling catheter were excluded. Postoperative fever was defined as a body temperature ≥38.3C. The researchers used a non-inferiority design with a 6% noninferiority margin and the null hypothesis (H0) that the infection risk is at least 6% higher in the experimental (E) than in the control (C) group; H0: C (antimicrobial prophylaxis group) − E (no antimicrobial prophylaxis group) ≥ Δ (6% noninferiority margin).
They also performed a multivariable, logistic regression regarding post transurethral resection of the prostate fever and antimicrobial prophylaxis with co-variates: (clot-)retention and operating time.
Salient findings of the study include:
· Of the patients 474 were included for multivariable analysis and 211/474 (44.5%) received antimicrobial prophylaxis vs 263/474 (55.5%) patients without antimicrobial prophylaxis.
· Antibiotics were fluoroquinolones in 140/211 (66.4%), cephazolin in 58/211 (27.5%) and amikacin in 13/211 (6.2%) patients.
· Fever occurred in 9/211 (4.4%) patients with antimicrobial prophylaxis vs 13/263 (4.9%) without antimicrobial prophylaxis.
· The researchers were able to exclude a meaningful increase in harm associated with omitting antimicrobial prophylaxis.
"Our findings show the safety of omitting antimicrobial prophylaxis in patients undergoing transurethral resection of the prostate without preoperative pyuria and a preoperative indwelling catheter," the researchers concluded.
Reference:
The study titled, "Antimicrobial Prophylaxis in Transurethral Resection of the Prostate: Results of a Randomized Trial," was published in The Journal of Urology.
DOI: https://doi.org/10.1097/JU.0000000000001638