NCT00292708已完成3 期
Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin
National Cancer Center, Japan7 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2004年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 7
- 主要终点
- Incidence of incisional surgical site infection (SSI)
研究概览
简要总结
To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery
详细描述
Use of prophylactic antibiotics in elective colorectal surgery is essential. Although single-dose prophylactic antibiotics are recommended, the efficacy of single-dose cephalosporin without metronidazole and oral antibiotics is not fully proven. We conducted a multicenter randomized trial of single-dose vs. three doses of the second-generation cephalosporin, cefmetazole.
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
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on)
- •Elective colorectal resection
排除标准
- •Emergent operation
- •No resection
- •Preoperative infectious diseases
- •Penicillin or cephalosporin allergy
- •Antibiotics administration before surgery
- •Inflammatory bowel diseases
- •Angina or myocardial infarction
- •Renal dysfunction
- •Diabetes mellitus
- •Steroid administration before surgery
结局指标
主要结局
Incidence of incisional surgical site infection (SSI)
次要结局
- Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay
研究者
研究点 (7)
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