Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359964
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-05
Brief Title:
Infective Complications in TP Biopsy Without Antibiotic Prophylaxis
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Infective Complications in Transperineal Prostate Biopsy Without Antibiotic Prophylaxis A Prospective Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective cohort study to delineate the infective outcomes and incidence after transperineal prostate biopsy with no antibiotic prophylaxis compared to the existing data on outcomes on patients receiving transperineal prostate biopsy with antibiotic prophylaxis
Detailed Description:
All consecutive patients receiving transperineal prostate biopsy in the PWH will be recruited to the exposure cohort after informed consent Antibiotic prophylaxis will not be given for patients in the exposure group All patients will undergo transperineal prostate biopsy in the usual manner and technique under the Ginsburg protocol Systematic and MRI-TRUS fusion for systematic plus targeted biopsy will be performed based on the usual clinical indications depending on the clinical need Follow-up data will be collected with particular interest on the assessment of infective complications
Prospectively collected data will also be retrieved from the electronic patient record ePR under the Hospital Authority to assess relevant information on infective complications for patients who received transperineal prostate biopsy in PWH and NDH from 2019 to 2023 These patients received antibiotic prophylaxis prior to their biopsies and eligible patients will be included as the control cohort for comparison Propensity score matching will be utilized in order to create a control group that is similar to the exposure group with balanced baseline Statistical analysis will be performed on the retrieve data
Prospectively collected data will also be retrieved from the electronic patient record ePR under the Hospital Authority to assess relevant information on infective complications for patients who received transperineal prostate biopsy in PWH and NDH from 2019 to 2023 These patients received antibiotic prophylaxis prior to their biopsies and eligible patients will be included as the control cohort for comparison Propensity score matching will be utilized in order to create a control group that is similar to the exposure group with balanced baseline Statistical analysis will be performed on the retrieve data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None