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

NCT03042091 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: 16D.204
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of post-operative clostridium difficile infection

  Up to 30 days post operation

• Incidence of adynamic ileus

  Up to 30 days post operation

• Incidence of cardiopulmonary complications

  Up to 30 days post operation

• Incidence of urinary tract infection

  Up to 30 days post operation

• Length of hospital stay

  Up to 30 days post operation

Study Arms (2)

Arm I (mechanical bowel prep, oral antibiotics)

ACTIVE COMPARATOR

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; Drug: Neomycin; Drug: Metronidazole Hydrochloride; Procedure: Therapeutic Conventional Surgery

Arm II (oral antibiotics)

EXPERIMENTAL

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

Drug: Neomycin; Drug: Metronidazole Hydrochloride; Procedure: Therapeutic Conventional Surgery

Interventions

Polyethylene Glycol DRUG

Given orally

Also known as: 25322-68-3, 57859, Ethanol, Glycol, Polyethylene Glycol 400

Arm I (mechanical bowel prep, oral antibiotics)

Neomycin DRUG

Given orally

Also known as: 1404-04-2, Neomycin Complex

Arm I (mechanical bowel prep, oral antibiotics); Arm II (oral antibiotics)

Metronidazole Hydrochloride DRUG

Given orally

Also known as: 69198-10-3, Flagyl, Metro I.V., Satric

Arm I (mechanical bowel prep, oral antibiotics); Arm II (oral antibiotics)

Therapeutic Conventional Surgery PROCEDURE

Undergo colorectal resection

Arm I (mechanical bowel prep, oral antibiotics); Arm II (oral antibiotics)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients undergoing emergent colorectal resections
• Patients who are decisionally-impaired and lack the mental capacity to give informed consent

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (1)

• Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.

  PMID: 36748942 DERIVED

Related Links

• Sidney Kimmel Cancer Center
• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Colorectal Neoplasms; Diverticulitis; Inflammatory Bowel Diseases; Surgical Wound Infection

Interventions

Polyethylene Glycols; Ethanol; Glycols; polyethylene glycol 400; Neomycin; Metronidazole; Benchmarking

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Diverticular Diseases; Gastroenteritis; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Aminoglycosides; Glycosides; Carbohydrates; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms

Study Officials

• Benjamin Phillips, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Phillips, MD

CONTACT

(215) 551-0360

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 3, 2017
• Study Start: September 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

US (1)