Combined Mechanical and Oral Antibiotic Bowel Preparation Versus Oral Antibiotics Alone for the Reduction of Surgical Site Infection Following Elective Colorectal Resection
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients undergoing emergent colorectal resections
- •Patients who are decisionally-impaired and lack the mental capacity to give informed consent
研究组 & 干预措施
Arm I (mechanical bowel prep, oral antibiotics)
Patients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
干预措施: Polyethylene Glycol (Drug)
Arm I (mechanical bowel prep, oral antibiotics)
Patients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
干预措施: Neomycin (Drug)
Arm I (mechanical bowel prep, oral antibiotics)
Patients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
干预措施: Metronidazole Hydrochloride (Drug)
Arm I (mechanical bowel prep, oral antibiotics)
Patients receive polyethylene glycol orally (PO), neomycin PO, and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
干预措施: Therapeutic Conventional Surgery (Procedure)
Arm II (oral antibiotics)
Patients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
干预措施: Neomycin (Drug)
Arm II (oral antibiotics)
Patients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
干预措施: Metronidazole Hydrochloride (Drug)
Arm II (oral antibiotics)
Patients receive neomycin PO and metronidazole hydrochloride PO on day -1. Patients undergo colorectal resection on day 0.
干预措施: Therapeutic Conventional Surgery (Procedure)
结局指标
主要结局
Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak
时间窗: 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.
次要结局
- Incidence of adynamic ileus(Up to 30 days post operation)
- Incidence of cardiopulmonary complications(Up to 30 days post operation)
- Incidence of urinary tract infection(Up to 30 days post operation)
- Length of hospital stay(Up to 30 days post operation)
- Incidence of post-operative clostridium difficile infection(Up to 30 days post operation)
- Incidence of mortality(Up to 30 days post operation)