Reduction of Prostate Biopsy Morbidity and Hospitalization Through a Modified Biopsy Protocol Bundle and Region-specific Antibiogram
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Maimonides Medical Center
- Enrollment
- 157
- Locations
- 1
- Primary Endpoint
- Rate of clinically significant post-biopsy complications
Study Overview
Brief Summary
Prostate biopsy is typically performed via either the transrectal or transperineal approach. This study is a case-control study being done to determine if a novel prostate biopsy protocol incorporating a transperineal approach, rectal swab to detect resistant bacteria and broad antibiotic prophylaxis will reduce infectious complications and hospital readmission compared to current biopsy practices.
Detailed Description
This will be a prospective multi-center cohort case-control study comparing a novel transperineal prostate biopsy protocol integrating measures to reduce post procedural infection (Cases) to traditional transrectal prostate biopsies (Controls). Eligible subjects will be identified through administrative records in the Urology clinics affiliated with Maimonides Medical Center. Eligible patients will be counseled about the risks and benefits of participation and offered enrollment into the study. Demographic data including age, comorbidities and past medical history will be extracted from the medical record.
Men meeting inclusion/exclusion criteria will be prospectively enrolled. The novel transperineal protocol will include the following: (Cases)
- Transperineal biopsy approach with avoidance of rectal flora
- MRI-ultrasound fusion-guided biopsies with reduced number of biopsy cores, where clinically indicated
- Rectal swab to identify the presence of fluoroquinolone resistant (FQR) bacteria
- Multi-antibiotic prophylaxis
- Urine culture, prostate tissue culture and rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.
Traditional biopsy protocol includes: (Controls)
- Transrectal approach
- Standard 12-core template
- Surgeon-specific antibiotic prophylaxis
- Urine culture, prostate tissue culture and FQR rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male patients greater than 18 years of age
- •Indication for prostate biopsy
Exclusion Criteria
- •Female patients
- •Male patients under 18 years of age
- •No indication for prostate biopsy
Outcomes
Primary Outcomes
Rate of clinically significant post-biopsy complications
Time Frame: 30 Days
1. Rate of any clinically significant post-biopsy complications including infectious complications and hospital readmissions within 30 days.
Secondary Outcomes
- 1. Number of individual complications within 30 days(30 Days)
Investigators
Ariel Schulman
Principal Investigator
Maimonides Medical Center