Mechanical Bowel Prep Randomized Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMount Sinai Hospital, Canada

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

Qualifiers

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

Treatments tested in this trial

  • IVA+OA versus IVA+MBP+OA

Treatment groups

1,062 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators