Clinical Trial: Enteral Feeding in the Post-Injury Open Abdomen

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title:

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 Summary: 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.
Sponsor: Denver Health and Hospital Authority

Current Primary Outcome: fascial closure rate [ Time Frame: participants will be followed for their hospital stay, which is on average expected to be 1 month ]

physical exam will document fascial closure


Original Primary Outcome: Same as current

Current Secondary Outcome: mortality [ Time Frame: participants will be followed for their hospital stay, which is on average expected to be 1 month ]

Original Secondary Outcome: Same as current

Information By: Denver Health and Hospital Authority

Dates:
Date Received: January 15, 2013
Date Started: January 2013
Date Completion: January 2018
Last Updated: November 28, 2016
Last Verified: November 2016