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NOT YET RECRUITING
NCT04931173
NA

Mechanical Bowel Prep Randomized Study

Sponsor: Mount Sinai Hospital, Canada

View on ClinicalTrials.gov

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

Interventions

OTHER

IVA+OA versus IVA+MBP+OA

Non-inferiority RCT comparing IVA+OA+MBP vs IVA+OA to reduce surgical site infection following colon surgery