Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 584
- 试验地点
- 5
- 主要终点
- Incidence and classification of surgical site infection (SSI)
研究概览
简要总结
The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.
详细描述
The use of antibiotic prophylaxis in patients who undergo elective colorectal surgery is now accepted universally. But the rout of administration should be systematic, oral, or both is controversial. Furthermore, although many trails have been performed, no trial limited to laparoscopic surgery is performed. We compare 2 approaches - oral and systemic versus systemic antibiotic prophylaxis - in limited to elective laparoscopic colorectal surgery.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection
排除标准
- •ECOG Performance Status >=2
- •Any organ dysfunction
- •Preoperative infectious disease
- •Antibiotic administration before surgery
- •Steroid administration before surgery
- •Neo-adjuvant radiation and/or chemo therapy
- •Severe diabetes mellitus
- •Pregnancy/lactational woman
- •Severe allergy
研究组 & 干预措施
IV
Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
干预措施: cefmetazole (Drug)
Oral/IV
2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
干预措施: kanamycin/metronidazole (Drug)
结局指标
主要结局
Incidence and classification of surgical site infection (SSI)
时间窗: Within the first 30 days after surgery
次要结局
- Incidence of colitis, other infectious diseases and other postoperative complications.(Within the first 30 days after surgery)
研究者
Hiroaki Hata
member
Japan Multinational Trial Organization