Colorectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases, Surgical Site Infection
Conditions
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.
Interventions
DRUGPolyethylene Glycol
Given orally
DRUGNeomycin
Given orally
Given orally
PROCEDURETherapeutic Conventional Surgery
Undergo colorectal resection
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| Length of hospital stay | Up to 30 days post operation | — |
| Incidence of mortality | Up to 30 days post operation | — |
| 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 |
Countries
United States
Contacts
Primary ContactBenjamin Phillips, MD
Outcome results
None listed