Randomized Controlled Trial of 3 vs 7 Days for Perioperative Antibiotic Prophylaxis for Patients With an Indwelling Catheter Prior to Holmium Laser Enucleation of the Prostate
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Infectious complications
研究概览
简要总结
To compare the risk of infectious complications (UTI, pyelonephritis, sepsis, hospital admission, ED visits) for patients with an indwelling urinary catheter (urethral or suprapubic) or CIC receiving 3 or 7 days of peri-operative antibiotic prophylaxis at time of Holmium Laser Enucleation of the Prostate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1. Candidate for HoLEP surgery
- •Must be 18 years or older.
- •The patient must be able to understand and willing to provide informed consent as described in this study protocol.
排除标准
- •1. Under the age of 18
- •Refuse to provide informed consent
- •Anticipated need for perineal urethrostomy
- •History of multi-drug resistant organism on urine culture that is not susceptible to any oral agents
研究组 & 干预措施
3 day prophylaxis
3 days of perioperative culture directed antibiotic prophylaxis will be prescribed to this group (to start 1 day prior to surgery). macrobid if preoperative culture is negative
干预措施: antibiotic prophylaxis (Drug)
7 day prophylaxis
7 days of perioperative culture directed antibiotic prophylaxis will be prescribed to this group (to start 4 day prior to surgery). macrobid if preoperative culture is negative
干预措施: antibiotic prophylaxis (Drug)
结局指标
主要结局
Infectious complications
时间窗: 0-90 days postoperatively
UTI, pyelonephritis, sepsis, hospital admission, ED visits
次要结局
- healthcare utilization(0-90days)