Is Mechanical Bowel Preparation Necessary to Reduce Surgical Site Infection Following Colon Surgery: a Randomized Controlled Trial

NCT04931173 NA NOT_YET_RECRUITING

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.

Details

Lead sponsor	Mount Sinai Hospital, Canada
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	1062
Start date	2025-03
Completion	2027-12

Conditions

• Colorectal Surgery

Interventions

• IVA+OA versus IVA+MBP+OA

Primary outcomes

• Surgical Site Infection Rate — 30 days following date of surgery
  Rate of overall surgical site infection