Pemberian Antibiotik Profilaksis Pada Biopsi Prostat Transperineal di RSUPN Dr. Cipto Mangunkusumo: Uji Klinis Acak Terkontrol
试验速览
- 阶段
- 2 期
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Incidence of infection complications
研究概览
简要总结
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.
详细描述
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 4.0 ng/mL 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The randomization process will be conducted before the study started. Computers will generate random numbers, which will put the participants into two groups. These numbers can only be accessed by the clinical research supporting unit team, while the investigators, surgeons, residents, nurses, and pharmacologists involved will be blinded to this information. To ensure patient blinding, the placebo will be manufactured as identical capsules.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cotrimoxazole
The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure.
干预措施: Cotrimoxazole (Drug)
Placebo
The placebo group will receive placebo q.d. 4 hours before the biopsy procedure.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of infection complications
时间窗: 14 days
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.
次要结局
- Rate of readmission(14 days)
研究者
dr. Agus Rizal Ardy Hariandy Hamid, Sp.U(K), Ph.D
Main Researcher
Indonesia University