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

Primary Purpose

Colorectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Polyethylene Glycol
Neomycin
Metronidazole Hydrochloride
Therapeutic Conventional Surgery
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Neoplasms

Eligibility Criteria

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

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

Sites / Locations

  • Thomas Jefferson UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (mechanical bowel prep, oral antibiotics)

Arm II (oral antibiotics)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak
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

Incidence of post-operative clostridium difficile infection
The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound
Incidence of adynamic ileus
The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound.
Incidence of cardiopulmonary complications
The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound
Incidence of urinary tract infection
The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound
Length of hospital stay
Incidence of mortality

Full Information

First Posted
January 31, 2017
Last Updated
August 20, 2018
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT03042091
Brief Title
Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery
Official Title
Combined Mechanical and Oral Antibiotic Bowel Preparation Versus Oral Antibiotics Alone for the Reduction of Surgical Site Infection Following Elective Colorectal Resection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases, Surgical Site Infection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (mechanical bowel prep, oral antibiotics)
Arm Type
Active Comparator
Arm Description
Patients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
Arm Title
Arm II (oral antibiotics)
Arm Type
Experimental
Arm Description
Patients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
Intervention Type
Drug
Intervention Name(s)
Polyethylene Glycol
Other Intervention Name(s)
25322-68-3, 57859, Ethanol, Glycol, Polyethylene Glycol 400
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
Neomycin
Other Intervention Name(s)
1404-04-2, Neomycin Complex
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
Metronidazole Hydrochloride
Other Intervention Name(s)
69198-10-3, Flagyl, Metro I.V., Satric
Intervention Description
Given orally
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo colorectal resection
Primary Outcome Measure Information:
Title
Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak
Description
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.
Time Frame
Up to 30 days post operation
Secondary Outcome Measure Information:
Title
Incidence of post-operative clostridium difficile infection
Description
The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound
Time Frame
Up to 30 days post operation
Title
Incidence of adynamic ileus
Description
The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound.
Time Frame
Up to 30 days post operation
Title
Incidence of cardiopulmonary complications
Description
The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound
Time Frame
Up to 30 days post operation
Title
Incidence of urinary tract infection
Description
The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound
Time Frame
Up to 30 days post operation
Title
Length of hospital stay
Time Frame
Up to 30 days post operation
Title
Incidence of mortality
Time Frame
Up to 30 days post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Phillips, MD
Phone
(215) 551-0360
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Phillips, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Phillips, MD
Phone
215-551-0360

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

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

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