A Prospective Randomized Trial of Antibiotic Prophylaxis Versus None Before Transperineal MRI-TRUS Fusion Guided Prostate Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 550
- 试验地点
- 3
- 主要终点
- Incidence of sepsis
研究概览
简要总结
Prostate biopsy is indicated in patients with suspected prostate cancer and has been traditionally performed through the rectum using antibiotic prophylaxis. Increasing antibiotic resistance of intestinal bacteria is causing a growing number of patients to get post-biopsy infections. Sepsis rate after transrectal biopsies is approximately 4-10%.
To reduce the risk of post-biopsy infections, transperineal approach in general anesthesia and antibiotic prophylaxis has been used. The investigators at Oslo University Hospital Aker developed MRI -TURS elastic image fusion guided transperineal prostate biopsy technique in local anesthesia and Bactrim prophylaxis as outpatient procedure. The investigators found 0.4% post-biopsy infection rate. Afterwards a pilot study using the same biopsy technique however without antibiotic prophylaxis was realized in 90 patients. None of these subjects experienced infection.
The investigators wish to perform a prospective randomized trial of antibiotic prophylaxis versus none before transperineal MRI-TRUS fusion guided prostate biopsy in local anesthesia in outpatient clinic.
详细描述
Background: Unnecessary use of antibiotics promotes antibiotic resistance. Efforts for antibiotic use reduction without increase the risk of serious infection complications are therefore needed.
Purpose: The aim of this trial is to compare the rates of infectious complication after transperineal prostate biopsy in patients with and without antibiotic prophylaxis.
Materials and methods
A total of 450 patients will be included in this trial. A 1:1 randomization to receive or not receive antibiotics prophylaxis will be performed using randomization system WebCRF-3 system. MRI-TRUS fusion prostate biopsy will be done with transperineal prostate approach in local anesthesia in outpatient clinic. In patients with normal MRI,12-core systematic prostate biopsies with 3D biopsy registration will be done according to the EAU guidelines. In patients with positive MRI, 2-4 targeted biopsies from the suspicious MRI areas will be realized and systematic prostate biopsies will also be done. All prostate biopsies will be performed using Koelis MRI-TRUS image fusion and organ based tracking system. Post-biopsy infection and any adverse events will be systematically prospectively registered in all patients. Pain during the local anesthesia application and during the biopsy procedure will be registered using Visual Analog Score, 10 points scale questionnaire.
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
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical indication for prostate cancer
排除标准
- •Patients with symptoms of urinary tract infection or positive findings on urine dipstic before biopsy
- •Patients with indwelling urethral catheter
- •Patients with immunodeficiency disorders
- •Patients with high risk for infective endocarditis [European Society of Cardiology]
- •Patients with a prosthetic aortic or pulmonary valve
- •Patients with previous infective endocarditis
- •Patients with congenital heart disease who are cyanotic and those who have had palliative shunts/conduits/other prostheses
- •Patients with a history of thromboembolic disease
- •Patients with a history of allergy to the study drug
- •Patients who do not wish to participate in the study
结局指标
主要结局
Incidence of sepsis
时间窗: Up to 30 days
Post biopsy sepsis will be defined by SIRS criteria
Incidence of post biopsy urinary tract infection
时间窗: Up to 30 days
Post biopsy urinary tract infection not demanding hospital admission within 30
次要结局
未报告次要终点
研究者
Eduard Baco
Principal investigator
Oslo University Hospital