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Mechanical Bowel Prep Randomized Study

Primary Purpose

Colorectal Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IVA+OA versus IVA+MBP+OA
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Surgery focused on measuring Surgical Site Infection, Mechanical Bowel Preparation, Randomized Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group A: IV and Oral antibiotics (IVA+OA)

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

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Surgical Site Infection Rate
    Rate of overall surgical site infection

    Secondary Outcome Measures

    Patient tolerability of the bowel preparation
    Validated 9-item questionnaire entitled: "Mayo Clinic Bowel Prep Tolerability Questionnaire" (Scale 1-4; lower score = better outcome)
    Length of stay
    length of stay in hospital following colorectal procedure
    30-day ER rate
    emergency room visit rate to any hospital within 30 days of surgery
    30-day readmission rate
    readmission rate to any hospital within 30 days of surgery

    Full Information

    First Posted
    June 11, 2021
    Last Updated
    October 18, 2023
    Sponsor
    Mount Sinai Hospital, Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04931173
    Brief Title
    Mechanical Bowel Prep Randomized Study
    Official Title
    Is Mechanical Bowel Preparation Necessary to Reduce Surgical Site Infection Following Colon Surgery: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    March 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mount Sinai Hospital, Canada

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Background: Colon surgery includes surgery for colon cancer, inflammatory bowel disease and other benign disease such as diverticulitis. In Canada, approximately 21,000 colon surgeries are performed annually. Following colon surgery, the most common complication is surgical site infection (SSI) and rates of up to 25% have been reported. The high volume of colon cancer surgery, coupled with high rates of SSI lead to considerably worse health care outcomes for patients including increased recovery time, length of stay and readmission. Currently, several different bowel preparations to reduce SSI are being used in Canada and there is significant practice variation due to lack of RCTs and conflicting practice guidelines. More recently, several large observational studies and a network meta-analysis have shown that a combination of intravenous antibiotics, mechanical bowel preparation and oral antibiotics (IVA+MBP+OA) is superior to IVA+MBP and IVA alone. Interestingly, these studies also showed that SSI rates for IVA+OA are comparable to IVA+MBP+OA. These data provide a strong rationale to conduct a RCT comparing IVA+OA versus IVA+MBP+OA to determine if MBP is a necessary part of the bowel preparation or if MBP can be safely omitted and the side effects of MBP avoided. Objectives: Therefore, the objectives are to conduct a multi-centre, parallel, two arm, non-inferiority RCT comparing IVA+MBP+OA versus IVA+OA to reduce SSI following colon surgery. Methods: The inclusion criteria are any patient (i) undergoing elective colon surgery, (ii) over the age of 18 years and (3) provides informed consent. Eligible patients at 4 centres across Canada will be randomized to one of two groups: IVA+OA+MBP or IVA+OA. The primary outcome for the trial is the overall rate of SSI at 30 days following surgery. Assuming an overall SSI rate of 7% with IVA+MBP+OA and a non-inferiority margin of 4.0%, 1062 patients will be required with a one sided alpha of 0.05 and a power of 80%. This non-inferiority margin was unanimously accepted as clinically meaningful by all of the Site Leads at participating centres. Primary analyses will be performed per-protocol in patients who received treatment as allocated and underwent colon surgery. Overall SSI rates at 30 days following surgery will be compared using a general linear model and non-inferiority will be declared if the upper limit of the one sided 95% confidence interval of the absolute risk difference of overall SSI following surgery does not include 4.0%. Relevance: This trial will be highly relevant to both patients and physicians as the results will provide definitive, high quality, patient-centred evidence about whether MBP is a necessary part of the optimal bowel preparation to reduce SSI and improve both patient experience and outcomes. These results will have significant potential to change practice in Canada and world-wide.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Surgery
    Keywords
    Surgical Site Infection, Mechanical Bowel Preparation, Randomized Controlled Trial

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1062 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A: IV and Oral antibiotics (IVA+OA)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group B: IV antibiotics, MBP and oral antibiotics (IVA+MBP+OA)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    IVA+OA versus IVA+MBP+OA
    Intervention Description
    Non-inferiority RCT comparing IVA+OA+MBP vs IVA+OA to reduce surgical site infection following colon surgery
    Primary Outcome Measure Information:
    Title
    Surgical Site Infection Rate
    Description
    Rate of overall surgical site infection
    Time Frame
    30 days following date of surgery
    Secondary Outcome Measure Information:
    Title
    Patient tolerability of the bowel preparation
    Description
    Validated 9-item questionnaire entitled: "Mayo Clinic Bowel Prep Tolerability Questionnaire" (Scale 1-4; lower score = better outcome)
    Time Frame
    5 minutes (completed in pre-operative holding area on the day of surgery)
    Title
    Length of stay
    Description
    length of stay in hospital following colorectal procedure
    Time Frame
    2-7 days
    Title
    30-day ER rate
    Description
    emergency room visit rate to any hospital within 30 days of surgery
    Time Frame
    30 days
    Title
    30-day readmission rate
    Description
    readmission rate to any hospital within 30 days of surgery
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: undergoing elective colon surgery for benign or malignant disease over the age of 18 years provides informed consent. Exclusion Criteria: known anaphylaxis to neomycin or metronidazole pregnancy or lactation chronic renal failure (serum creatinine > 220 umol/L).

    12. IPD Sharing Statement

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    Mechanical Bowel Prep Randomized Study

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