Prospective Randomized Clinical Trial on Oral and Intravenous Antibiotic Prophylaxis in Colorectal Surgery (COLORAL1).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Wound infection
研究概览
简要总结
Elective colon surgery is considered a clean-contaminated procedure, with a Surgical Site Infection (SSI) rate not inferior to 10%. For many years the role of Mechanical Bowel Preparation (MBP) has been universally recognized as an effective measure to reduce colonic bacterial load and consequently SSI rate, mostly in European Countries. However, in the early 1970s has been demonstrated a further SSI risk reduction in colon surgery if oral non-absorbable antibiotics were added to MBP and for the next 30 years this became the standard of care prior to elective colon surgery, especially in the US. Nowadays, Meta-analyses have demonstrated that MBP does not impact upon postoperative morbidity or mortality, and as such it should not be prescribed routinely. Conversely, recent evidence has suggested that there may be a role for combined MBP and oral antibiotics, or oral antibiotics alone in the prevention of surgical site infection (SSI).
The aim of this trial is to evaluate the efficacy of preoperative oral antibiotics prophylaxis for preventing surgical site infections in elective colorectal surgery.
详细描述
This study is a Multicenter, Prospective, Randomized, Controlled Trial on preoperative oral antibiotics prophylaxis in colorectal surgery.
INCLUSION & EXCLUSION CRITERIA:
All consecutive patients undergoing elective colorectal resection should be included in the trial.
Exclusion criteria:
- Emergency procedures
- Appendicectomy (unless procedure involves a right hemicolectomy)
- Primarily urological/gynecological or vascular procedure - e.g. ileal conduit, Hartmann's during ovarian surgery, resection during abdominal aortic aneurysm repair.
- Diagnostic laparotomy/laparoscopy without intestinal resection.
- Surgery involving multi-visceral surgery - e.g. pelvic exenteratio
- Controindication for mechanical preparation
- Allergy to used drugs
- Patients who refuse to participate in the study
- Patients with intra-abdominal sepsis before surgery (abscess).
- Patients who received antibiotics for any reason within two weeks prior to surgery.
- Patients who do not comply strictly with the assigned prophylaxis regimen.
- Patients who cannot be followed at least 4 weeks after 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oral + Parenteral prophylaxis
Oral antibiotic drugs:
- Bimixin (Neomicin + Bacitracin tablet) 25000 UI + 2500 UI: h. 8-16-24 the day before surgery if the procedure takes place in the morning; h. 16-24-8 if the procedure takes place in the afternoon.
Systemic antibiotic drugs:
- Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery.
- in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg.
干预措施: Oral antibiotic drugs (Drug)
Oral + Parenteral prophylaxis
Oral antibiotic drugs:
- Bimixin (Neomicin + Bacitracin tablet) 25000 UI + 2500 UI: h. 8-16-24 the day before surgery if the procedure takes place in the morning; h. 16-24-8 if the procedure takes place in the afternoon.
Systemic antibiotic drugs:
- Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery.
- in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg.
干预措施: Parenteral prophylaxis (Drug)
Only parenteral prophylaxis
- Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery.
- in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg.
干预措施: Parenteral prophylaxis (Drug)
结局指标
主要结局
Wound infection
时间窗: up to 30 days after surgery
Incidence of surgical site infections (superficial or deep)
次要结局
- Perioperative complication(up to 30 days after surgery)
- Anastomotic dehiscence(up to 30 days after surgery)
- Post-operative ileus(up to 30 days after surgery)
- Extra-abdominal complications(up to 30 days after surgery)
- Readmission(up to 30 days after surgery)
- Reoperation(up to 30 days after surgery)
- Length of hospital stay(up to 30 days after surgery)
- Mortality(up to 30 days after surgery)
- Adverse Drug Reactions(up to 30 days after surgery)
研究者
Alberto Arezzo
Prof.
University of Turin, Italy