Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Rate of Surgical Site Infection
研究概览
简要总结
This is a randomized, controlled, parallel study to determine the efficiency of oral antibiotics in reduction of surgical site infection (SSI) in rectal cancer surgery.
详细描述
Patients undergoing rectal cancer surgery in a single centre will assigned randomly to combined preoperative oral antibiotics (metronidazole and erythromycin) and perioperative intravenous antibiotics (cefmetazole) (oral+intravenous group) or to perioperative intravenous antibiotics (cefmetazole) alone (intravenous group). The primary endpoint is the overall rate of SSI.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Have a planned of resection of rectum
- •Have signed approved informed consent form for the study.
排除标准
- •Significant simultaneous surgical procedure (e.g., liver resection of metastasis)
- •Bacterial infection at the time of surgery or antimicrobial therapy up to 4 weeks before surgery
- •Preoperative severe impairment in renal function (creatinine clearance (MDRD) < 30 ml/min)
- •Allergy on the study drugs .
研究组 & 干预措施
Oral with Intravenous
Oral metronidazole and erythromycine administration on the day before surgery with intravenous cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
干预措施: Oral antibiotic (Drug)
Oral with Intravenous
Oral metronidazole and erythromycine administration on the day before surgery with intravenous cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
干预措施: Intravenous antibiotic (Drug)
Oral with Intravenous
Oral metronidazole and erythromycine administration on the day before surgery with intravenous cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
干预措施: Mechanical Bowel Preparation (Drug)
Intravenous
Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
干预措施: Intravenous antibiotic (Drug)
Intravenous
Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
干预措施: Mechanical Bowel Preparation (Drug)
结局指标
主要结局
Rate of Surgical Site Infection
时间窗: 0 to 30 days
次要结局
未报告次要终点
研究者
Rybakov Evgeny, MD
Dr. Med. Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation
State Scientific Centre of Coloproctology, Russian Federation