Prostate Cancer Clinical Trial
Official title:
A Randomized Controlled Trial to Investigate the Infectious Outcomes of Intrarectal Povidone-iodine Cleansing Plus Formalin Disinfection of Needle Tip During Transrectal Ultrasound Guided Prostate Biopsy
The main purpose of this study is to compare the infectious outcomes of intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy. The secondary objective is to evaluate predictive factors of infectious complications after prostate biopsy. Data will be prospectively collected from patients who will undergo prostate biopsy in a single high volume urology center. The patients will be randomized to two different groups: group A - rectal cleansing and disinfection of the needle tip vs group B - controls.
Prostate cancer is the most common neoplasm of solid organs in Brazil. Definitive diagnosis
of the tumor is established through prostate biopsy, indicated in patients with elevated
levels of PSA or suspicious rectal examination. The ultrasound or MRI-guided prostate biopsy
is mostly performed through the transrectal route worldwide. Although it is a relatively safe
procedure, transrectal prostate biopsy (TRUSB) can present several complications, such
bleeding, acute urinary retention or infection. Infectious complications are an important
concern for the urologist and have different presentation, ranging from isolated fever to
severe sepsis. Antibiotic prophylaxis is an effective widely used practice, however, due to
increasing rates of bacterial resistance, there is a growing trend in the incidence of
infectious complications after TRUSB. Therefore, alternative strategies to decrease
infections rates following biopsies are welcome. Our aim was to compare the infectious
complications of intrarectal povidone-iodine cleansing associated to formalin disinfection of
biopsy needle tip at prostate biopsy.
A prospective controlled study will be conducted enrolling 1152 consecutive prostate biopsies
in a single center high volume urology Brazilian Public Hospital. The patients will be
randomized at a 1: 1 ratio for two different groups: group A - rectal cleansing and
disinfection of the needle tip vs. Group B - controls at transrectal ultrasound guided
prostate biopsy. Patients will obtain a urine culture 48 hours after biopsy and complete a
telephone interview 7 days after undergoing the procedure. The primary endpoint will be the
rate of infectious complications, defined as 1 or more of the following events: fever ≥37.8
ºC; urinary tract infection (UTI) or sepsis (standardized definition). We will also evaluate
the predictive factors of infectious complications
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