CompletedPhase 4ACTRN12622000149763

Rectal and urethral flora in patients undergoing transrectal ultrasound guided prostate biopsy: clinical implications.

Comparison of infectious complications in patients undergoing transrectal ultrasound guided prostate biopsy receiving targeted antibiotic prophylaxis according to rectal and expressed prostatic secretion swab cultures versus empiric antibiotic prophylaxis: a prospective cohort study.


Sponsor

Sotirios Gatsos

Enrollment

200 participants

Start Date

Aug 28, 2019

Study Type

Interventional

Conditions

Summary

The role of rectal flora in infectious complications after transrectal ultrasound guided prostate biopsy (TRUS-Bx) is well documented, however there is a lack of evidence regarding urethral and prostatic flora. The aim of our study is to investigate the role of targeted antibiotic prophylaxis (TAP) after rectal and urethral swab compared to empiric antibiotic prophylaxis (EAP) for the prevention of infectious complications after TRUS-PBx. Study's primary outcome is the difference in infectious complications rates after TRUS-PBx between patients receiving EAP versus patients receiving TAP according to culture results of rectal swab and urethral swab of expressed prostatic secretions. We hypothesise that TAP which includes urethral swab can provide an added benefit by identifying a higher percentage of resistant bacteria carriers.


Eligibility

Sex: MalesMin Age: 40 Yearss

Inclusion Criteria1

  • Male patients with clinical and/or laboratory findings indicative of prostate cancer, namely abnormal digital rectal examination findings, elevated prostate specific antigen and suspicious imaging. Also, patients with previous non diagnostic biopsies who undergo a repeat biopsy.

Exclusion Criteria3

  • Presence of indwelling bladder catheter.
  • Inability to receive the proposed antibiotic prophylaxis (i.e allergies).
  • Patients subjected to saturation biopsy.

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Interventions

Patients in intervention group are subjected to cultures of rectal swab and urethral swab of expressed prostatic secretions. At the time of the first visit samples are collected by a single urologist.

Patients in intervention group are subjected to cultures of rectal swab and urethral swab of expressed prostatic secretions. At the time of the first visit samples are collected by a single urologist. At first, rectal swab sample is retrieved, followed by digital rectal examination and prostatic massage. Finally, urethral swab is used to collect expressed prostatic secretions. The sample is collected after retraction of prepuce and cleaning of urethral meatus with normal saline. A swab is then inserted approximately 2cm into urethra. Samples are sent to microbiology department for cultures. A predetermined antibiotic panel was used for rectal cultures with the following anibiotics: amoxycillin, ampicillin, amoxycillin/clavulanic acid, cefaclor, ceftazidime, amikacin, imipenem, norfloxacin, levofloxacin, ciprofloxacin, tigecycline, colistin and gentamycin. The antibiotic panel used for urethral cultures varied according to isolated bacteria. Based on culture results, patients are contacted and instructed to receive targeted antibiotic prophylaxis for a total of 5 days, initiated 1 day prior to prostate biopsy. Antibiotic selection was guided by known allergies, antimicrobial sensitivity, the provided minimum inhibitory concentration (MIC) and in compliance with the local antibiotic protocol of the department, which also determined the dose of the selected antibiotics. No complimentary instructions are given regarding pre-biopsy enema. Patients are subjected to twelve core TRUS-PBx with an 18G biopsy needle by a urologist. The approximate duration of the procedure is 10 to 15 minutes. The occurrence of infectious complications is investigated and verified at the time of biopsy results announcement by interviewing patients. At the same time, patients' adherence to given instructions is investigated by interviewing the patients and by drug tablet return. The allocation to the groups was carried out during the first visit to Urology outpatient clinic. Those not willing to give samples for culture and those who were referred by office urologists, directly for TRUS-Bx, were assigned to empiric antibiotic prophylaxis group and the rest of the patients were assigned to targeted antibiotic prophylaxis group.


Locations(1)

Greece

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ACTRN12622000149763