About this trial
Following colon surgery, surgical site infection (SSI) is the most common complication and leads to longer recovery time for patients and increased health care costs. Currently, there is high quality evidence to show that the combination of intravenous antibiotics (IVA), mechanical bowel preparation (MBP) and oral antibiotics (OA) is the most effective bowel preparation to reduce SSI. However, there are no studies comparing IVA+MBP+OA and IVA+OA. This is an important question because if IVA+OA works the same as IVA+MBP+OA, then MBP may be safely omitted as part of the bowel preparation to reduce SSI and patients would avoid the side effects of MBP prior to their surgery. Therefore, the objective is to perform a trial to determine if IVA+OA works the same as IVA+MBP+OA to reduce SSI following colon surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
undergoing elective colon surgery for benign or malignant disease
over the age of 18 years
provides informed consent.
Disqualifiers
known anaphylaxis to neomycin or metronidazole
pregnancy or lactation
chronic renal failure (serum creatinine > 220 umol/L).
Trial design
Parallel
Treatments tested in this trial
IVA+OA versus IVA+MBP+OA
Other interventionNon-inferiority RCT comparing IVA+OA+MBP vs IVA+OA to reduce surgical site infection following colon surgery
Treatment groups
Trial outcomes
Primary outcomes
Surgical Site Infection Rate
Rate of overall surgical site infection
Secondary outcomes
Patient tolerability of the bowel preparation
Validated 9-item questionnaire entitled: "Mayo Clinic Bowel Prep Tolerability Questionnaire" (Scale 1-4; lower score = better outcome)
Length of stay
length of stay in hospital following colorectal procedure
30-day ER rate
emergency room visit rate to any hospital within 30 days of surgery
30-day readmission rate
readmission rate to any hospital within 30 days of surgery
Locations
Sponsors and contacts
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