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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03042091
• Other study ID #: 16D.204
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 2016
• Est. completion date: October 2021

Study information

• Verified date: August 2018
• Source: Thomas Jefferson University
• Contact: Benjamin Phillips, MD
• Phone: (215) 551-0360
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: October 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Communicable Diseases
• Diverticulitis
• Infection
• Inflammatory Bowel Diseases
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Polyethylene Glycol
Given orally
• Neomycin
Given orally
• Metronidazole Hydrochloride
Given orally

Procedure:
• Therapeutic Conventional Surgery
Undergo colorectal resection

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of hospital stay		Up to 30 days post operation
Secondary	Incidence of mortality		Up to 30 days post operation

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital