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Enteral Feeding in the Post-Injury Open Abdomen

D

Denver Health and Hospital Authority

Status

Completed

Conditions

Trauma to the Abdomen

Study type

Observational

Funder types

Other

Identifiers

NCT01853735
13-0077

Details and patient eligibility

About

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.

Full 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.

Enrollment

515 patients

Sex

All

Ages

18 to 98 years old

Volunteers

No 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.

Trial design

515 participants in 4 patient groups

bowel injury, NPO
Description:
Patients with bowel injury who remain nil-per-os (fed nothing)
bowel injury, EN
Description:
Patients with bowel injury who are fed by enteral nutrition (EN)
no bowel injury, NPO
Description:
Patients without bowl injury who remain nil-per-os (fed nothing)
no bowel injury, EN
Description:
Patient without bowl injury who are fed by enteral nutrition (EN)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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