EUCTR2014-002345-21-ES进行中（未招募）1 期
Antibiotic prophylaxis oral vs parenteral + parenteral in colonic surgery: a prospective, randomized, multicenter clinical trial. - ATB-PROF
Dr Eloy Espin0 个研究点目标入组 536 人开始时间: 2014年10月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 536
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult patients over 18 years of age diagnosed with malignant or benign disease with indication for segmental colon resection, or total colectomy for the same indications, without medical contraindication to surgery.
- •Patients who agree to participate voluntarily in the study and signs an informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 336
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •- Patients who refuse to participate in the study.
- •- Patients undergoing mechanical bowel preparation the day before surgery.
- •- Patients with intraabdominal sepsis before surgery (abscess).
- •- Patients who received preoperative antibiotics for any reason within two weeks prior to surgery.
- •- Patients who have allergies to study drugs.
- •- Patients who do not comply strictly with the assigned prophylaxis regimen.
- •- Patients that cannot be followed for at least 4 weeks after surgery.
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