Prostate Cancer Clinical Trial
Official title:
Pemberian Antibiotik Profilaksis Pada Biopsi Prostat Transperineal di RSUPN Dr. Cipto Mangunkusumo: Uji Klinis Acak Terkontrol
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.
Status | Recruiting |
Enrollment | 78 |
Est. completion date | July 6, 2023 |
Est. primary completion date | July 6, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years and older |
Eligibility | Inclusion Criteria: - Patient with lower urinary tract symptoms aged >45 years with either PSA levels of 4.0 ng/mL or higher or abnormal findings on digital rectal examination (DRE) - Patient with a negative initial urine culture / urinalysis test Exclusion Criteria: - Patients who refuses to undergo transperineal prostate biopsy - Patients who refuses to participate in the research - Patient who is unable to communicate effectively - Patient with a documented history of cotrimoxazole allergy - Patient who has consumed antibiotics for other indications prior to undergoing prostate biopsy - Patient with urinary tract infection symptoms prior to undergoing prostate biopsy - Patient with a history of immunodeficiency disorders or long-term corticosteroid use - Patient with a history of prostate cancer - Patient with a history of prior prostate biopsy |
Country | Name | City | State |
---|---|---|---|
Indonesia | Dr. Cipto Mangunkusumo Hospital | Jakarta Pusat | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of infection complications | The rate of infection complications, including bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis, will be measured in both treatment and placebo groups in 24 hours postoperatively. | 24 hours | |
Primary | Incidence of infection complications | The rate of infection complications, including bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis, will be measured in both treatment and placebo groups in 7 days postoperatively. | 7 days | |
Primary | Incidence of infection complications | The rate of infection complications, including bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis, will be measured in both treatment and placebo groups in 14 days postoperatively. | 14 days | |
Secondary | Rate of readmission | The rate of readmission will also be assessed in 7 days postoperatively. | 7 days | |
Secondary | Rate of readmission | The rate of readmission will also be assessed in 14 days postoperatively. | 14 days |
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