Recruiting

Early Phase 1

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

Sponsor:

Thomas Jefferson University

Code:

NCT03042091

Conditions

Colorectal Neoplasms

Diverticulitis

Inflammatory Bowel Diseases

Surgical Site Infection

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Polyethylene Glycol

Neomycin

Metronidazole Hydrochloride

Therapeutic Conventional Surgery

Study Details

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.

Conditions

Colorectal Neoplasms

Diverticulitis

Inflammatory Bowel Diseases

Surgical Site Infection

Study ID

NCT03042091

Start date

Sep, 2016

Status verified date

Aug, 2018

Completion date

Oct, 2021

Anticipated

Primary completion date

Oct, 2020

Anticipated

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

experimental: Arm II (oral antibiotics)

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

Interventions

Polyethylene Glycol

Given orally

Neomycin

Given orally

Metronidazole Hydrochloride

Given orally

Therapeutic Conventional Surgery

Undergo colorectal resection

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Benjamin Phillips, MD

(215) 551-0360

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Benjamin Phillips, MD

215-551-0360

More Information

Sponsor

Thomas Jefferson University

Last update posted

Aug 22, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2018-08-22.