Clincosm LogoSign in Get a demo

Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery

Sponsor
Thomas Jefferson University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03042091
Collaborator
(none)
224
Enrollment
1
Location
2
Arms
61
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized clinical trial studies how well neomycin and metronidazole hydrochloride with or without polyethylene glycol work in reducing infection in patients undergoing elective colorectal surgery. Polyethylene glycol, may draw water from the body into the colon, flushing out the contents of the colon. Antibiotics, like neomycin and metronidazole hydrochloride, may stop bacteria from growing. It is not yet known whether it's better to give preoperative neomycin and metronidazole hydrochloride with or without polyethylene glycol in reducing surgical site infection after colorectal surgery.

Condition or Disease Intervention/Treatment Phase
  • Drug: Polyethylene Glycol
  • Drug: Neomycin
  • Drug: Metronidazole Hydrochloride
  • Procedure: Therapeutic Conventional Surgery
 Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. To estimate the difference in rates of surgical site infection following elective colorectal resections in patients given a preoperative mechanical bowel prep with oral antibiotics as compared to preoperative oral antibiotics alone.
SECONDARY OBJECTIVES:
  1. To determine rates of post-operative clostridium difficile infection, adynamic ileus, cardiopulmonary complications, urinary tract infection, length of stay and mortality in patients given preoperative oral antibiotics with a mechanical bowel prep versus preoperative antibiotics alone.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
224 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Combined Mechanical and Oral Antibiotic Bowel Preparation Versus Oral Antibiotics Alone for the Reduction of Surgical Site Infection Following Elective Colorectal Resection
Actual Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (mechanical bowel prep, oral antibiotics)

Patients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.

Drug: Polyethylene Glycol
Given orally
Other Names:
  • 25322-68-3
  • 57859
  • Ethanol
  • Glycol
  • Polyethylene Glycol 400

    • Drug: Neomycin
    Given orally
    Other Names:
  • 1404-04-2
  • Neomycin Complex

    • Drug: Metronidazole Hydrochloride
    Given orally
    Other Names:
  • 69198-10-3
  • Flagyl
  • Metro I.V.
  • Satric

    • Procedure: Therapeutic Conventional Surgery
    Undergo colorectal resection
    Experimental: Arm II (oral antibiotics)

    Patients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.

    Drug: Neomycin
    Given orally
    Other Names:
  • 1404-04-2
  • Neomycin Complex

    • Drug: Metronidazole Hydrochloride
    Given orally
    Other Names:
  • 69198-10-3
  • Flagyl
  • Metro I.V.
  • Satric

    • Procedure: Therapeutic Conventional Surgery
    Undergo colorectal resection

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak [Up to 30 days post operation]

      The difference in incidence of SSI (antibiotics [ABX] - ABX + prep) will be calculated with an upper 95% confidence bound. Exploratory analysis will consider stratum specific estimates of differences in subgroups defined by BMI and diabetes status.

    Secondary Outcome Measures

    1. Incidence of post-operative clostridium difficile infection [Up to 30 days post operation]

      The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound

    2. Incidence of adynamic ileus [Up to 30 days post operation]

      The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound.

    3. Incidence of cardiopulmonary complications [Up to 30 days post operation]

      The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound

    4. Incidence of urinary tract infection [Up to 30 days post operation]

      The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound

    5. Length of hospital stay [Up to 30 days post operation]

    6. Incidence of mortality [Up to 30 days post operation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients undergoing ileocolic resections, partial and total colectomies, and rectal resections for neoplasm, inflammatory bowel disease, or diverticulitis

    • Subjects with the mental capacity to give informed consent

    Exclusion Criteria:

    • Patients undergoing emergent colorectal resections

    • Patients who are decisionally-impaired and lack the mental capacity to give informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thomas Jefferson University Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Thomas Jefferson University

    Investigators

    • Principal Investigator: Benjamin Phillips, MD, Thomas Jefferson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT03042091
    Other Study ID Numbers:
    • 16D.204
    First Posted:
    Feb 3, 2017
    Last Update Posted:
    Aug 22, 2018
    Last Verified:
    Aug 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Surgical Wound Infection
    Colorectal Neoplasms
    Inflammatory Bowel Diseases
    Diverticulitis
    Metronidazole
    Ethanol
    Neomycin

    Study Results

    No Results Posted as of Aug 22, 2018