Chemoprophylaxis during transrectal prostate needle biopsy: critical analysis through randomized clinical trial
Abstract
PURPOSE: To compare the efficacy of three chemoprophylaxis approaches in prevention of post-transrectal biopsy infectious complications (TBICs).
METHODS: Patients were randomly assigned to receive ciprofloxacin 3 days 500 mg B.I.D 3 days starting the night prior to biopsy (standard prophylaxis), augmented prophylaxis using ciprofloxacin and single preprocedure shot of 160 mg gentamicin IM (augmented prophylaxis) and rectal swab culture-based prophylaxis (targeted prophylaxis). Patients were assessed 2 weeks prior to biopsy, at biopsy and 2 weeks after. Primary end point was occurrence of post-TBICs that included simple UTI, febrile UTI or sepsis. Secondary end points were post-biopsy change in the inflammatory markers (TLC, ESR and CRP), unplanned visits, hospitalization and occurrence of fluoroquinolones resistance (FQ-R; bacterial growth on MacConkey agar plate with 10 μg/ml ciprofloxacin) in the fecal carriage of screened men.
RESULTS: Between April/2015 and January/2017, standard, augmented and targeted prophylaxes were given to 163, 166 and 167 patients, respectively. Post-TBICs were reported in 43 (26%), 13 (7.8%) and 34 (20.3%) patients following standard, augmented and targeted prophylaxes protocols, respectively (P = 0.000). Post-TBICs included UTI in 23 (4.6%), febrile UTI in 41 (8.2%) and sepsis in 26 (5.2%) patients. Significantly lower number of post-biopsy positive urine culture was depicted in the augmented group (P = 0.000). The number of biopsy cores was…
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: 166 participants or records.
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