A prospective randomized trial of 1-day versus 3-day antibiotic prophylaxis for transrectal ultrasound guided prostate biopsy
Abstract
PURPOSE: To compare the incidence of infection between a 1 day and a 3 day antibiotic prophylaxis regimen for transrectal ultrasound (TRUS) guided prostate biopsy in a prospective, randomized open-label trial.
MATERIALS AND METHODS: TRUS examination was performed in the left lateral decubitus position using a Brüel and Kjaer 7 MHz rectal probe. Biopsies were carried out with an 18 gauge Tru-cut needle fired by the hand-held Biopsy gun. An average of eight core biopsies (range 6 to 12) was taken. From May 15, 2000 to May 16, 2001, 363 patients were enrolled in this study. Patients were randomized to receive either 1 day or 3 days of fluroquinolone antibiotic prophylaxis, consisting of either ciprofloxacin or levofloxacin orally. Antibiotics were begun at least 1 hour prior to biopsy. Seven days later, telephone follow-up was obtained.
RESULTS: Two (0.55%) of the 363 patients, one in each group, had an episode of sepsis. No urinary tract infection was reported. Traumatic complications were only minor and no significant difference was observed between both groups: hematospermia (p> 0.4), hematuria (p>0.1) and rectorragia (p>0.2) being reported most frequently.
CONCLUSION: There is no clinically nor statistically significant difference between a 1 day and 3 day antibiotic prophylaxis regimen for patients undergoing TRUS guided biopsies.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 363 participants or records.
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