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
NCT number | NCT03879486 |
Other study ID # | BIOPSY1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 31, 2017 |
Est. completion date | July 24, 2019 |
Verified date | March 2020 |
Source | Hospital de Transplante Doutor Euryclides de Jesus Zerbini |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1257 |
Est. completion date | July 24, 2019 |
Est. primary completion date | July 24, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Signature of the consent term; - Agreement with the study follow-up protocol; - Indication of biopsy due to increased PSA (> 2.5), abnormal rectal touch or patients under active surveillance protocol Exclusion Criteria: - Existence of cognitive deficit that impedes the reading and comprehension of the EHIC; - Allergy to ciprofloxacin or iodine |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Transplantes Euryclides de Jesus Zerbini | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Hospital de Transplante Doutor Euryclides de Jesus Zerbini |
Brazil,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infectious complications | compare the infectious outcomes of intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy | 1 week | |
Secondary | evaluate predictive factors of infectious complications after prostate biopsy. | evaluate predictive factors of infectious complications after prostate biopsy. | 1 week |
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