[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100433980":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":24,"locations":23,"responsibleParty":31,"collaborators":23,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":23,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":23,"enrollmentInfo":44,"targetDuration":23,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":57,"whyStopped":23,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":23},{"fullName":5,"class":6},"Mount Sinai Hospital, Canada","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: IV and Oral antibiotics (IVA+OA)","ACTIVE_COMPARATOR","Patients will receive cefazolin 2g IV and metronidazole 500 mg IV administered by the anesthesiologist within 60 minutes prior to the skin incision on the day of surgery. Standardized re-dosing of cefazolin 2g IV will occur every 4 hours and metronidazole 500 mg IV will occur every 8 hours during the surgical procedure. Following surgery, no further IVA will be given for SSI prophylaxis. In addition, patients will self-administer 1g neomycin and 1g metronidazole orally at 1500, 1700 and 2300 hours the day before surgery. Following this, they will not receive any further OAs for SSI prophylaxis.",[13],"Other: IVA+OA versus IVA+MBP+OA",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B: IV antibiotics, MBP and oral antibiotics (IVA+MBP+OA)","Patients will receive IVA and OA per Group A. In addition, patients will stay on clear fluids and self-administer a 2L polyethylene glycol MBP orally, between 1500 and 2300 hours on the day before surgery.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"IVA+OA versus IVA+MBP+OA","Non-inferiority RCT comparing IVA+OA+MBP vs IVA+OA to reduce surgical site infection following colon surgery",[9,15],null,[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Erin Kennedy, MD, PhD","CONTACT","4165864800","6872","erin.kennedy@sinaihealth.ca",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Erin Kennedy","Colorectal Surgeon; Department Head, Division of General Surgery","100433980","mechanical-bowel-prep-randomized-study-100433980",false,"NCT04931173","Mechanical Bowel Prep Randomized Study","Is Mechanical Bowel Preparation Necessary to Reduce Surgical Site Infection Following Colon Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* undergoing elective colon surgery for benign or malignant disease\n* over the age of 18 years\n* provides informed consent.\n\nExclusion Criteria:\n\n* known anaphylaxis to neomycin or metronidazole\n* pregnancy or lactation\n* chronic renal failure (serum creatinine \\> 220 umol\u002FL).","ALL","18 Years",{"count":45,"type":46},1062,"ESTIMATED","INTERVENTIONAL",[49],"NA","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.",[52],"Colorectal Surgery",[54,55,56],"Surgical Site Infection","Mechanical Bowel Preparation","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-06-17",{"date":60,"type":61},"2026-06-22","ACTUAL",{"date":63,"type":46},"2026-09",{"date":65,"type":46},"2028-12",{"name":5,"class":6}]