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

Early Phase 1

• Conditions: Diverticulitis; Colorectal Neoplasms; Inflammatory Bowel Diseases; Surgical Site Infection
• Interventions: Drug: Polyethylene Glycol; Drug: Metronidazole Hydrochloride; Drug: Neomycin; Procedure: Therapeutic Conventional Surgery

• Registration Number: NCT03042091
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22
• Primary Completion: 2020-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 224

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (oral antibiotics)	Metronidazole Hydrochloride	Patients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
Arm II (oral antibiotics)	Therapeutic Conventional Surgery	Patients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
Arm I (mechanical bowel prep, oral antibiotics)	Therapeutic Conventional Surgery	Patients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
Arm I (mechanical bowel prep, oral antibiotics)	Metronidazole Hydrochloride	Patients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
Arm I (mechanical bowel prep, oral antibiotics)	Polyethylene Glycol	Patients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
Arm I (mechanical bowel prep, oral antibiotics)	Neomycin	Patients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
Arm II (oral antibiotics)	Neomycin	Patients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.

Primary Outcome Measures

Name	Time	Method
Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak	Up to 30 days post operation	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

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

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States