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

Thomas Jefferson University

Status and phase

Unknown

Early Phase 1

Conditions

Surgical Site Infection

Colorectal Neoplasms

Inflammatory Bowel Diseases

Diverticulitis

Treatments

Drug: Metronidazole Hydrochloride

Drug: Polyethylene Glycol

Procedure: Therapeutic Conventional Surgery

Drug: Neomycin

Study type

Interventional

Funder types

Other

Identifiers

NCT03042091

16D.204

Details and patient eligibility

About

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.

Full 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.

Enrollment

224 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

224 participants in 2 patient groups

Arm I (mechanical bowel prep, oral antibiotics)

Active Comparator group

Description:

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

Treatment:

Drug: Neomycin

Drug: Polyethylene Glycol

Procedure: Therapeutic Conventional Surgery

Drug: Metronidazole Hydrochloride

Arm II (oral antibiotics)

Experimental group

Description:

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

Treatment:

Drug: Neomycin

Procedure: Therapeutic Conventional Surgery