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Mechanical Bowel Prep Randomized Study
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.
Official title: Is Mechanical Bowel Preparation Necessary to Reduce Surgical Site Infection Following Colon Surgery: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1062
Start Date
2025-03
Completion Date
2027-12
Last Updated
2024-11-20
Healthy Volunteers
No
Conditions
Interventions
IVA+OA versus IVA+MBP+OA
Non-inferiority RCT comparing IVA+OA+MBP vs IVA+OA to reduce surgical site infection following colon surgery