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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
224
Given orally
Given orally
Given orally
Undergo colorectal resection
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
RECRUITINGIncidence 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.
Time frame: Up to 30 days post operation
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Up to 30 days post operation
Length of hospital stay
Time frame: Up to 30 days post operation
Incidence of mortality
Time frame: Up to 30 days post operation
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