Intravenous Versus Combined Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Elective Colorectal Surgery (COMBINE)
Elective Colorectal Surgery
About this trial
This is an interventional prevention trial for Elective Colorectal Surgery focused on measuring Antimicrobial prophylaxis, Colorectal surgery, Surgical Site Infection, Postoperative morbidity
Eligibility Criteria
Inclusion Criteria:
- Age > 18
- Laparoscopic or non-laparoscopic elective colorectal surgery
Exclusion Criteria:
- Non elective colorectal surgery (emergent surgery and/or reintervention or revision of a previous colorectal procedure)
- Significant concomitant surgical procedure (e.g., liver resection for metastasis)
- Bacterial infection at the time of surgery or antimicrobial therapy up to 2 weeks before surgery
- Inflammatory bowel disease
- Severe obesity (defined as a BMI >35 kg/m2)
- Known history of hypersensitivity to β-lactams and imidazoles
- Preoperative severe impairment in renal function (creatinine clearance (MDRD) < 30 ml/min)
- Patients with known colonization with multidrug-resistant digestive bacteria, especially multidrug-resistant gram-negative bacteria (requiring specific infection control measures)
- Allergy to lactose, galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption (rare metabolic disease)
- Pregnant women, breastfeeding women, women of childbearing age without effective contraceptive- Refusal to participate or inability to provide informed consent
Sites / Locations
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
ornidazole
placebo
oral antibiotic prophylaxis using ornidazole, which has a spectrum of activity extended to most anaerobic bacteria and whose pharmacokinetic profile allows a single administration the day before surgery, in addition to intravenous antibiotic prophylaxis could be more effective than intravenous antibiotic prophylaxis alone using cephalosporin in reducing the incidence of SSI after elective colorectal surgery. Given the number of patients operated of colorectal surgery each year, the study is of significant clinical importance
oral antibiotic prophylaxis using ornidazole, which has a spectrum of activity extended to most anaerobic bacteria and whose pharmacokinetic profile allows a single administration the day before surgery, in addition to intravenous antibiotic prophylaxis could be more effective than intravenous antibiotic prophylaxis alone using cephalosporin in reducing the incidence of SSI after elective colorectal surgery. Given the number of patients operated of colorectal surgery each year, the study is of significant clinical importance