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

Combined Mechanical and Oral Antibiotic Bowel Preparation Versus Oral Antibiotics Alone for the Reduction of Surgical Site Infection Following Elective Colorectal Resection

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Neoplasms; Inflammatory Bowel Diseases; Surgical Site Infection; Diverticulitis
• Intervention / Treatment: Drug: Polyethylene Glycol; Drug: Neomycin; Drug: Metronidazole Hydrochloride; Procedure: Therapeutic Conventional 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.

• Study Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Benjamin Phillips, MD; Phone Number: (215) 551-0360

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University
      • Contact: Benjamin Phillips, MD; Phone Number: 215-551-0360

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Flagyl; 69198-10-3; 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: Flagyl; 69198-10-3; Metro I.V.; Satric; Procedure: Therapeutic Conventional Surgery; Undergo colorectal resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 30 days post operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 30 days post operation
Incidence of adynamic ileus	The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound.	Up to 30 days post operation
Incidence of cardiopulmonary complications	The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound	Up to 30 days post operation
Incidence of urinary tract infection	The difference in incidence of SSI (ABX - ABX + prep) will be calculated with an upper 95% confidence bound	Up to 30 days post operation
Length of hospital stay		Up to 30 days post operation
Incidence of mortality		Up to 30 days post operation

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Thomas Jefferson University Hospital
• Sidney Kimmel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Wound Infection; Diverticular Diseases; Infections; Communicable Diseases; Colorectal Neoplasms; Inflammatory Bowel Diseases; Surgical Wound Infection; Diverticulitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Ethanol; Metronidazole; Neomycin
• Other Study ID Numbers: 16D.204

Drug and device information, study documents

• 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