Ignite Creation Date:
2024-05-06 @ 4:26 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04985110
Status:
UNKNOWN
Last Update Posted:
2021-08-05
First Post:
2021-07-26
Brief Title:
Administration of Antibiotic Prophylaxis for Transperineal Prostate Biopsy in Cipto Mangunkusumo Hospital
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
Pemberian Antibiotik Profilaksis Pada Biopsi Prostat Transperineal di RSUPN Dr Cipto Mangunkusumo Uji Klinis Acak Terkontrol
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
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 randomized controlled trial aims to compare the rate of perioperative infection complications in transperineal prostate biopsy between the group that receives prophylactic antibiotic and the group that receives placebo The types of infection studied included bacteriuria urinary tract infection UTI UTI with fever febrile UTI and sepsis This study hypothesized that the administration of prophylactic antibiotics during transperineal prostate biopsy would result in lower rates of perioperative infection complications
Detailed Description:
Prostate cancer screenings will be conducted in all patients aged 45 years with lower urinary tract symptoms LUTS through PSA test and digital rectal examination DRE Those with PSA levels of 40 ngmL or higher or other abnormal findings on DRE will be recommended to undergo transperineal prostate biopsy In addition participants will be offered to participate in this clinical trial in which participants will be randomly assigned into two groups one group will receive prophylactic antibiotic while the other group will receive placebo
The randomization process will be conducted before the biopsy procedure Computers will generate random numbers which will put the participants into two groups These numbers can only be accessed by the research monitor Clinical Research Supporting Unit of IMERI FMUI while the investigators surgeons residents and nurses involved will be blinded to this information To ensure patient blinding the placebo and cotrimoxazole forte 960 mg will be reformed as identical as possible in capsule preparation
The primary outcomes of this clinical trial are the rate of perioperative infection complications including bacteriuria urinary tract infection UTI UTI with fever febrile UTI and sepsis in 24 hours 7 days and 14 days postoperatively The secondary outcomes of this clinical trial are the rate of readmission
The randomization process will be conducted before the biopsy procedure Computers will generate random numbers which will put the participants into two groups These numbers can only be accessed by the research monitor Clinical Research Supporting Unit of IMERI FMUI while the investigators surgeons residents and nurses involved will be blinded to this information To ensure patient blinding the placebo and cotrimoxazole forte 960 mg will be reformed as identical as possible in capsule preparation
The primary outcomes of this clinical trial are the rate of perioperative infection complications including bacteriuria urinary tract infection UTI UTI with fever febrile UTI and sepsis in 24 hours 7 days and 14 days postoperatively The secondary outcomes of this clinical trial are the rate of readmission
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