NCT01853735

Enteral Feeding in the Post-Injury Open Abdomen

Enteral Nutrition in the Open Abdomen

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 515 (actual)
• Sponsor: Denver Health and Hospital Authority · Academic / Other
• Sex: All
• Age: 18 Years – 98 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Trauma to the Abdomen

Timeline

• Start date: 2013-01-01
• Primary completion: 2022-06-29
• Completion: 2022-06-29
• First posted: 2013-05-15
• Last updated: 2022-09-21

Locations

1 site across 1 country: United States