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NCT04931173
Mechanical Bowel Prep Randomized Study
Conditions: Colorectal Surgery
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1062
Sponsor: Mount Sinai Hospital, Canada
Summary
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
Inclusion Criteria:
* undergoing elective colon surgery for benign or malignant disease
* over the age of 18 years
* provides informed consent.
Exclusion Criteria:
* known anaphylaxis to neomycin or metronidazole
* pregnancy or lactation
* chronic renal failure (serum creatinine \> 220 umol/L).
Source: ClinicalTrials.gov (NCT04931173). StuddyBuddy aggregates publicly available trial information.