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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases, Surgical Site Infection

Intervention / Treatment
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* Drug: Polyethylene Glycol
* Drug: Neomycin
* Drug: Metronidazole Hydrochloride
* Procedure: Therapeutic Conventional Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (mechanical bowel prep, oral antibiotics)<br>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<br>* Given orally<br>* Other names: Polyethylene Glycol 400;Drug: Neomycin<br>* Given orally<br>* Other names: Neomycin Complex;Drug: Metronidazole Hydrochloride<br>* Given orally<br>* Other names: Satric;Procedure: Therapeutic Conventional Surgery<br>* Undergo colorectal resection<br>|
| Experimental: Arm II (oral antibiotics)<br>Patients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0. | Drug: Neomycin<br>* Given orally<br>* Other names: Neomycin Complex;Drug: Metronidazole Hydrochloride<br>* Given orally<br>* Other names: Satric;Procedure: Therapeutic Conventional Surgery<br>* Undergo colorectal resection<br>|

What is the study measuring?
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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 |