Enteral Feeding in the Post-Injury Open Abdomen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

515 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2022-06-29

Brief Summary

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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.

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Detailed Description

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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

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Trauma to the Abdomen

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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bowel injury, NPO

Patients with bowel injury who remain nil-per-os (fed nothing)

No interventions assigned to this group

bowel injury, EN

Patients with bowel injury who are fed by enteral nutrition (EN)

No interventions assigned to this group

no bowel injury, NPO

Patients without bowl injury who remain nil-per-os (fed nothing)

No interventions assigned to this group

no bowel injury, EN

Patient without bowl injury who are fed by enteral nutrition (EN)

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

98 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No