2025-520725-20-00招募中2 期
Selective decontamination of the digestive tract in preventing surgical site infections in elective colorectal surgery: a randomised controlled trial (SELDDEC Trial)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 322
- 试验地点
- 1
- 主要终点
- Incidence of surgical site infection
研究概览
简要总结
To determine if preoperative oral antibiotics, in the absence of mechanical bowel preparation, reduces the incidence of surgical site infection in elective colorectal surgery
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patients (aged ≥ 18 years) scheduled for elective laparoscopic, open and/or robotic assisted colon or rectal surgery for benign or malignant disease
排除标准
- •inability to provide informed consent (2) acute surgery for bleeding, perforation or obstruction, (3) uncontrolled diabetes mellitus, (4) preoperative steroid use, (5) antibiotic use within 2 weeks of proposed elective surgery date and (6) previous allergic reaction to the antibiotics utilised in this study. (7) Patients with contraindications to neomycin and erythromycin. (8) Patients with renal and hepatic impairment. (9) Patients who have a positive pregnancy test. (10) Patients requiring more extensive antibiotic prophylaxis.
结局指标
主要结局
Incidence of surgical site infection
Incidence of surgical site infection
次要结局
- Infectious complications other than surgical site infections, length of hospital stay, postoperative complications as per Clavien Dindo Classification, anastomotic leakage and mortality
研究者
Colin Peirce
Scientific
University Hospital Limerick
研究点 (1)
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