Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle.
Prostate biopsy is the golden standard for diagnose of prostate cancer. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. Due to the transrectal path the biopsy needle will bring bacteria from the colon into tissue. The patent should always receive prophylactic antibiotics to reduce the risk of clinical infection. Infections related to transrectal prostate biopsy (TRUSbx) are increasing in parallel with rising antibiotic resistance. The investigators have in an ex-vivo setting previously shown a drastic reduction in bacterial transfer across the colon wall using a novel biopsy needle designed to minimize bacterial transfer. Biopsy of prostatectomy specimen using the novel needle has shown biopsy quality equal to the tru cut biopsy needle used today. This is the first human pilot aiming to evaluate if biopsy quality of the novel needle is equal to the reference tru cut biopsy needle in prostate biopsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
20
Trans Rectal UltraSound guided Prostate Biopsy
Helsingborg Hospital
Helsingborg, Skåne County, Sweden
prostate biopsy length (measured by pathologist)
Length of biopsy specimen in millimeters
Time frame: within 21 days post biopsy
prostate biopsy fragmentation
The number of sections the biopsy specimen is made of
Time frame: within 21 days post biopsy
General appearance of biopsy assessed by pathologist (biopsy quality)
General quality of biopsy specimen on a scale from 0-3 (no biopsy, poor, good, excellent)
Time frame: within 21 days post biopsy
prostate biopsy length (measured in biopsy needle chamber)
Length of biopsy specimen in millimeters
Time frame: within 21 days post biopsy
prostate biopsy length (measured in after removal from biopsy chamber)
Length of biopsy specimen in millimeters
Time frame: within 21 days post biopsy
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