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

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ClinicalTrials.gov Identifier: NCT03042091
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

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
Colorectal Neoplasms Diverticulitis Inflammatory Bowel Diseases Surgical Site Infection Drug: Polyethylene Glycol Drug: Neomycin Drug: Metronidazole Hydrochloride Procedure: Therapeutic Conventional Surgery Early Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021


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




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


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042091


Contacts
Contact: Benjamin Phillips, MD (215) 551-0360

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Benjamin Phillips, MD    215-551-0360      
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Benjamin Phillips, MD Thomas Jefferson University

Additional Information:
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03042091     History of Changes
Other Study ID Numbers: 16D.204
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 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:
Infection
Communicable Diseases
Inflammatory Bowel Diseases
Colorectal Neoplasms
Surgical Wound Infection
Diverticulitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Rectal Diseases
Wound Infection
Postoperative Complications
Pathologic Processes
Intraabdominal Infections
Anti-Bacterial Agents
Neomycin
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors