NCT02089568已完成4 期
Are Prophylactic Antibiotics Necessary Before Laparoscopic Living Kidney Donation? A Double Blind, Randomised, Controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Rate of infection after surgery
研究概览
简要总结
The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney donation surgery prevent infection.
详细描述
Subjects undergoing laparoscopic donor nephrectomy will be randomised to either a single dose of intravenous co-amoxiclav or placebo prior to surgery. Outcome measures include any infections, length of stay and costs
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included.
- •Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is our normal practice.
- •Women of child-bearing age taking adequate contraception will be included.
排除标准
- •Patients with a known allergy to penicillin or other antibiotics.
- •Patients with MRSA colonisation.
- •Participation in another investigational study within the previous 90 days.
- •Pregnant or breast-feeding women.
研究组 & 干预措施
Drug: co-amoxiclav
Experimental
experimental
干预措施: Co-Amoxiclav (Drug)
Control
Placebo Comparator
comparator
干预措施: Normal Saline (Drug)
结局指标
主要结局
Rate of infection after surgery
时间窗: 24 months
次要结局
- Length of hospital stay(24 months)
- Return to work and normal activities(24 months)
- Quality of life(24 months)
- Relative costs(24 months)
- Ultrasonic evidence of wound healing(24 months)
- Readmission rates(24 months)
- Antibiotic associated side effects(24 months)
研究者
Nizam Mamode
Consultant Transplant Surgeon
Guy's and St Thomas' NHS Foundation Trust
研究点 (1)
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