Mechanical Bowel Preparation and Oral Antibiotic Prophylaxis vs. Mechanical Bowel Preparation in Colorectal Surgery With i.v. Antibiotic Prophylaxis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Surgical Site Infections
研究概览
简要总结
The investigators perform a case-control study to compare preparation before elective colorectal surgery. The first group is a prospective patient - registry in all patients with mechanical bowel preparation (MBP) and oral antibiotic prophylaxis the day before colorectal surgery. The second group is a historic collective of patients with MBP only and colorectal surgery. The cases were matches in American Society of Anesthesiologists (ASA) physical status classification system, BMI, operative procedure and risk factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 colorectal resections
排除标准
- 未提供
研究组 & 干预措施
Oral Antibiotics
The patients get mechanical bowel preparation and oral antibiotic prophylaxis with 4g Paromomycin (Paromomycin Sulfate Powder) and 1 g Metronidazole p.o. and perioperative i.v. antibiotic prophylaxis with Ertepanem 1g i.v.
干预措施: Paromomycin Sulfate Powder (Drug)
结局指标
主要结局
Surgical Site Infections
时间窗: 30 days (exact 30 days after the Operation date)
Any kind of surgical site infection in the postoperative course.
次要结局
- Anastomotic Leak(30 days (exact 30 days after the Operation date))
研究者
Dr. Boris Jansen-Winkeln
Consultant Colorectal Surgery
University of Leipzig