CTRI/2024/03/063953尚未招募4 期
Outcome of guideline directed pre-operative prophylactic single dose/day vs extended prophylactic antibotics for urological surgeries A Randomized controlled study
Rajath S Shetty1 个研究点 分布在 1 个国家目标入组 337 人开始时间: 2024年3月18日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 337
- 试验地点
- 1
- 主要终点
- 30-day rate of clinical UTI after urological procedures with single dose/day preoperative antibiotic against extended antibiotic therapy
研究概览
简要总结
| Post-procedural |
| genito-urinary tract infection (UTI) is a frequent occurrence in the clinical |
| setting with associated morbidity, cost of treatment and possible long-term |
| sequelae. Most urological procedures are either Class 1 or 2 procedures with recommended |
| single-shot antibiotic prophylaxis for most. Urological surgeries differ from |
| other surgeries in that (a) Flora that causes surgical site infections is |
| markedly different from cutaneous flora, with more pre-disposition of |
| gram-negative enterobacteriaceae (b) Use of continuous high pressure |
| irrigation in endo-urological surgeries to distend the endoscopic surgical |
| field, resulting in pyelovenous and pyelolymphatic backflow predisposing to |
| development of bacteremia and endotoxiemia, and (c) Frequent use of foreign |
| bodies like stents, catheter or nephrostomy before and after the surgery. As |
| a result, the general recommendations for surgical site infections are not |
| directly applicable to endourological surgery [1]. Even though, most guidelines recommend only |
| a single dose/day of antibiotic prophylaxis for most endourological cases, |
| the use of antibiotics in the peri-operative period is extremely diverse with |
| wide differences between different regions, different hospitals, and even |
| different consultants in same surgical unit. In real-world practice, |
| peri-operative antibiotics use is heavily driven by apprehension of gram-negative |
| bacteremia, endotoxemia and sepsis. Such use stands against the larger |
| community goal of minimizing use of antibiotics wherever feasible. Therefore, |
| there is huge need to reduce this clinical gap between guidelines and actual |
| clinical practice(1). This study seeks to find |
| out if there is any difference between the guideline directed preoperative |
| prophylactic single dose/day vs extended prophylactic antibiotic course for |
| urological surgeries in a prospective randomized manner. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective urological surgeries under general anesthesia.
- •Age ≥5 to ≤ 75 years.
排除标准
- •Patient refusing to consent to study or is unwilling to participate or with multiple comorbidities.
结局指标
主要结局
30-day rate of clinical UTI after urological procedures with single dose/day preoperative antibiotic against extended antibiotic therapy
时间窗: At baseline, at 1 week after surgey and 30 days post surgey
次要结局
- 1-week rate of clinical UTI, 1-week and 30-day bacteriuria rates, 1-week and 30-day asymptomatic bacteriuria rates, 1-week and 30-day septicemia rates
研究者
Rajath S Shetty
AIIMS New Delhi
研究点 (1)
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