Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections
NCT ID: NCT03496142
Last Updated: 2018-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
340 participants
INTERVENTIONAL
2018-04-30
2020-05-31
Brief Summary
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The aim of this study would be to compare in a prospective randomized trial the rate of infection with transperineal versus transrectal approach.
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Detailed Description
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Post-biopsy infection is becoming a more and more challenging situation due to the increase of incidence and development of antibiotic resistant germs.
The aim of this study would be to compare in a prospective randomized trial the rate of infection with transperineal vs transrectal approach.
Patient presenting an indication of prostate biopsy (PSA elevation, suspicious lesion at digital rectal, suspicious lesion on MRI) would be randomized 1:1 among transrectal vs transperineal biopsies.
Post-biopsy infection would be monitored by systemic urine analysis at one, two and four weeks after procedure and in case of clinical symptoms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Transperineal prostate biopsy
Patient will have a transperineal prostate biopsy.
Transperineal prostate biopsy
Puncture of 12 to 30 percutaneous prostate core biopsies through the perineum with a transrectal ultrasound probe guidance. The procedure would be performed with the Artemis (Eigen) device allowing topographic recording of the puncture and MRI / ultrasound image fusion in order to target the MRI suspected lesion.
Transrectal prostate biopsy
Patient will have a transrectal prostate biopsy.
Transrectal prostate biopsy
Patient would undergo 12 to 30 transrectal prostate core biopsies through the rectum with a transrectal ultrasound probe guidance. The procedure would be performed with the Artemis (Eigen) device allowing topographic recording of the puncture and MRI / ultrasound image fusion in order to target the MRI suspected lesion.
Interventions
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Transperineal prostate biopsy
Puncture of 12 to 30 percutaneous prostate core biopsies through the perineum with a transrectal ultrasound probe guidance. The procedure would be performed with the Artemis (Eigen) device allowing topographic recording of the puncture and MRI / ultrasound image fusion in order to target the MRI suspected lesion.
Transrectal prostate biopsy
Patient would undergo 12 to 30 transrectal prostate core biopsies through the rectum with a transrectal ultrasound probe guidance. The procedure would be performed with the Artemis (Eigen) device allowing topographic recording of the puncture and MRI / ultrasound image fusion in order to target the MRI suspected lesion.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Impossibility for prostate biopsy (e.g. major anal stenosis or history of anal amputation)
* Antibiotic treatment within three months before prostate biopsy
18 Years
MALE
No
Sponsors
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Institut Mutualiste Montsouris
OTHER
Responsible Party
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Principal Investigators
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Alexandre INGELS, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Mutualiste Montsouris
Locations
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Institut Mutualiste Montsouris
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Alexandre INGELS, MD
Role: primary
Other Identifiers
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URO-03-2017
Identifier Type: -
Identifier Source: org_study_id
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