Enteral Nutrition in the Open Abdomen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 1
- 主要终点
- fascial closure rate
研究概览
简要总结
The purpose of this study is to determine if Enteral Feeding (EN) in patients with a traumatic bowel injury requiring an open abdomen impacts outcomes. Patients who receive EN will be compared to those who remain nil-per-os (NPO). Additionally, an internal study control will be performed by analyzing concurrent injured patients requiring an open abdomen who did not have a bowel injury.
Specific aims:
Hypothesis 1: EN in patients with a traumatic bowel injury requiring an open abdomen improves fascial closure rate compared to patients who remain NPO.
Hypothesis 2: EN in patients with a traumatic bowel injury requiring an open abdomen reduces infectious complications compared to patients who remain NPO.
Hypothesis 3: EN in patients with a traumatic bowel injury requiring an open abdomen have a lower mortality rate compared to patients who remain NPO.
详细描述
Fascial closure is determine by the primary physician and should be recorded in the operative record. This record will be accessed to determine if this variable is accomplished. Additionally, any dehiscence complication will be recorded (which would impact the long-term fascial closure rate). Infectious complications (abscess, pneumonia, etc) will be adjudicated by the primary clinician and any record of this in the patient chart will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 98 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with a post-injury open abdomen
排除标准
- •Patients to be excluded from analysis include deaths within 24 hours, identification of injury > 24 hours, and those transferred from an outside hospital > 24 hours following initial injury.
结局指标
主要结局
fascial closure rate
时间窗: participants will be followed for their hospital stay, which is on average expected to be 1 month
physical exam will document fascial closure
次要结局
- mortality(participants will be followed for their hospital stay, which is on average expected to be 1 month)
研究者
Ryan Lawless
Physician
Denver Health and Hospital Authority