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临床试验/NCT03913039
NCT03913039已完成不适用

Reduction of Prostate Biopsy Morbidity and Hospitalization Through a Modified Biopsy Protocol Bundle and Region-specific Antibiogram

Maimonides Medical Center1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
157
试验地点
1
主要终点
Rate of clinically significant post-biopsy complications

研究概览

简要总结

Prostate biopsy is typically performed via either the transrectal or transperineal approach. This study is a case-control study being done to determine if a novel prostate biopsy protocol incorporating a transperineal approach, rectal swab to detect resistant bacteria and broad antibiotic prophylaxis will reduce infectious complications and hospital readmission compared to current biopsy practices.

详细描述

This will be a prospective multi-center cohort case-control study comparing a novel transperineal prostate biopsy protocol integrating measures to reduce post procedural infection (Cases) to traditional transrectal prostate biopsies (Controls). Eligible subjects will be identified through administrative records in the Urology clinics affiliated with Maimonides Medical Center. Eligible patients will be counseled about the risks and benefits of participation and offered enrollment into the study. Demographic data including age, comorbidities and past medical history will be extracted from the medical record.

Men meeting inclusion/exclusion criteria will be prospectively enrolled. The novel transperineal protocol will include the following: (Cases)

  1. Transperineal biopsy approach with avoidance of rectal flora
  2. MRI-ultrasound fusion-guided biopsies with reduced number of biopsy cores, where clinically indicated
  3. Rectal swab to identify the presence of fluoroquinolone resistant (FQR) bacteria
  4. Multi-antibiotic prophylaxis
  5. Urine culture, prostate tissue culture and rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.

Traditional biopsy protocol includes: (Controls)

  1. Transrectal approach
  2. Standard 12-core template
  3. Surgeon-specific antibiotic prophylaxis
  4. Urine culture, prostate tissue culture and FQR rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients greater than 18 years of age
  • Indication for prostate biopsy

排除标准

  • Female patients
  • Male patients under 18 years of age
  • No indication for prostate biopsy

结局指标

主要结局

Rate of clinically significant post-biopsy complications

时间窗: 30 Days

1. Rate of any clinically significant post-biopsy complications including infectious complications and hospital readmissions within 30 days.

次要结局

  • 1. Number of individual complications within 30 days(30 Days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ariel Schulman

Principal Investigator

Maimonides Medical Center

研究点 (1)

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