Mechanical Bowel Prep Randomized Study

NCT04931173 | Not Yet Recruiting DMC

• 1 other identifier: PJT-165836
• Study Type: interventional
• Target: 1,062
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Surgery

Keywords

Surgical Site Infection; Mechanical Bowel Preparation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection Rate

  Rate of overall surgical site infection

  30 days following date of surgery

Secondary Outcomes (4)

• Patient tolerability of the bowel preparation

  5 minutes (completed in pre-operative holding area on the day of surgery)

• Length of stay

  2-7 days

• 30-day ER rate

  30 days

• 30-day readmission rate

  30 days

Study Arms (2)

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.

Other: IVA+OA versus IVA+MBP+OA

Group B: IV antibiotics, MBP and oral antibiotics (IVA+MBP+OA)

ACTIVE COMPARATOR

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.

Other: IVA+OA versus IVA+MBP+OA

Interventions

IVA+OA versus IVA+MBP+OA OTHER

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

Group A: IV and Oral antibiotics (IVA+OA); Group B: IV antibiotics, MBP and oral antibiotics (IVA+MBP+OA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing elective colon surgery for benign or malignant disease
• over the age of 18 years
• provides informed consent.

You may not qualify if:

• known anaphylaxis to neomycin or metronidazole
• pregnancy or lactation
• chronic renal failure (serum creatinine \> 220 umol/L).

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Related Publications (1)

• Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.

  PMID: 36748942 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Erin Kennedy, MD, PhD

CONTACT

4165864800; erin.kennedy@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colorectal Surgeon; Department Head, Division of General Surgery

Model Details: This is a multi-centre, parallel, two-arm, non-inferiority randomized controlled trial comparing IVA+OA+MBP versus IVA+OA to reduce surgical site infection following colon surgery

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 20, 2024

Record last verified: 2024-11