Enteral Feeding in the Post-Injury Open Abdomen

Enteral Nutrition in the Open Abdomen

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01853735

Enrollment

515

Registered

2013-05-15

Start date

2013-01-31

Completion date

2022-06-29

Last updated

2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma to the Abdomen

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 98 Years

Healthy volunteers

Inclusion criteria

* All patients with a post-injury open abdomen

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
fascial closure rate	participants will be followed for their hospital stay, which is on average expected to be 1 month	physical exam will document fascial closure

Secondary

Measure	Time frame	Description
mortality	participants will be followed for their hospital stay, which is on average expected to be 1 month	subject mortality status

Other

Measure	Time frame	Description
infectious complications	participants will be followed for their hospital stay, which is on average expected to be 1 month	physical exam and imaging will be reviewed to assess infections

Countries

United States

Outcome results