Preoperative Oral Antibiotics and Surgical Site Infections in Colon Surgery Without Mechanical Bowel Preparation. A Prospective, Multicentre, Single Blinded, Randomized Trial (ORALEV Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 536
- 试验地点
- 3
- 主要终点
- Wound infection
研究概览
简要总结
Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used.
Experimental group: Patients undergoing elective colorectal surgery that involves, colonic resection.
The antibiotic prophylaxis in this group will be composed of:
An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses) the day before surgery.
Control group: Patients undergoing elective colorectal surgery that involves, colonic resection.
The antibiotic prophylaxis in this group will be composed of:
An intravenous antibiotic pattern of cefuroxime 1g and metronidazole 1,5gr during anesthetic induction.
In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc.
There won´t be a placebo treatment. Subject compliance will be evaluated according to the usual practice in surgical care field
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients presenting colonic pathology
- •The surgery is not contraindicated
- •Diagnosis of colorectal neoplasia or diverticular disease with surgical indication (stenosis, chronic constipation, recurrent infections etc ..)
- •Indication of segmentary resection or total colectomy
- •Patients who agree to participate voluntarily in the study and signed an informed consent.
排除标准
- •Patients who refuse to participate in the study.
- •Patients undergoing mechanical colon preparation the day before surgery.
- •Patients with rectal cancer
- •Patients with intra-abdominal sepsis before surgery (abscess, diverticulitis).
- •Patients who received preoperative antibiotics for any reason in the two weeks prior to surgery.
- •Patients with inflammatory bowel disease (ulcerative colitis, Crohn's disease and indeterminate colitis)
- •Patients presenting allergy to the drugs under study.
- •Patients that will not strictly follow the assigned prophylaxis regimen
- •Patients undergoing urgent surgery (<24h)
研究组 & 干预措施
Oral + Parenteral prophylaxis
干预措施: Colorectal Surgery (Procedure)
Oral + Parenteral prophylaxis
干预措施: Extra dosage - cefuroxime (750mg) I.V (Drug)
Oral + Parenteral prophylaxis
干预措施: Ciprofloxacin 750 mg oral (Drug)
Oral + Parenteral prophylaxis
干预措施: Metronidazole 250 mg oral (Drug)
Oral + Parenteral prophylaxis
干预措施: Cefuroxime 1.5 g Intravenous (Drug)
Oral + Parenteral prophylaxis
干预措施: Metronidazole 1 g Intravenous (Drug)
Only Parenteral prophylaxis
干预措施: Extra dosage - cefuroxime (750mg) I.V (Drug)
Only Parenteral prophylaxis
干预措施: Colorectal Surgery (Procedure)
Only Parenteral prophylaxis
干预措施: Cefuroxime 1.5 g Intravenous (Drug)
Only Parenteral prophylaxis
干预措施: Metronidazole 1 g Intravenous (Drug)
结局指标
主要结局
Wound infection
时间窗: 30 days
Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently
次要结局
- Hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Cardiac complications(30 days after surgery)
- Nephro-urinary complications(30 days after surgery)
- Respiratory complications(30 days after surgery)
- Neurological complications(30 days after surgery)
- Direct Adverse Drug Reactions(24 hours since the drug is taken)
- Gastrointestinal complications(30 days after surgery)
- Iatrogenic problems(30 days after surgery)
- Bleeding problems(30 days after surgery)
- Occlusive problems(30 days from surgery)
- Impaired healing(30 days after surgery)
- Vascular Complications(30 days after surgery)
- Local infection(30 days after surgery)
- Local complications(30 days after surgery)