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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (mechanical bowel prep, oral antibiotics) | Active Comparator | 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) | Experimental | Patients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene Glycol | Drug | Given orally |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Phillips, MD | Contact | (215) 551-0360 |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Phillips, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36748942 | Derived | Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2. |
| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center | View source |
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| Neomycin | Drug | Given orally |
|
|
| Metronidazole Hydrochloride | Drug | Given orally |
|
|
| Therapeutic Conventional Surgery | Procedure | Undergo colorectal resection |
|
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 |
| Thomas Jefferson University Hospital | View source |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D004238 | Diverticulitis |
| D015212 | Inflammatory Bowel Diseases |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D000431 | Ethanol |
| D006018 | Glycols |
| C000595213 | polyethylene glycol 400 |
| D009355 | Neomycin |
| D008795 | Metronidazole |
| D019985 | Benchmarking |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008330 | Management Audit |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D015397 | Program Evaluation |
| D011787 | Quality of Health Care |
| D011785 | Quality Assurance, Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
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