Enteral Feeding in the Post-Injury Open Abdomen

NCT01853735 | Completed

• 1 other identifier: 13-0077
• Study Type: observational
• Target: 515
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma to the Abdomen

Outcome Measures

Primary Outcomes (1)

• fascial closure rate

  physical exam will document fascial closure

  participants will be followed for their hospital stay, which is on average expected to be 1 month

Secondary Outcomes (1)

• mortality

  participants will be followed for their hospital stay, which is on average expected to be 1 month

Other Outcomes (1)

• infectious complications

  participants will be followed for their hospital stay, which is on average expected to be 1 month

Study Arms (4)

bowel injury, NPO

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

bowel injury, EN

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

no bowel injury, NPO

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

no bowel injury, EN

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

Eligibility Criteria

• Age: 18 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients requiring an open abdomen following trauma will be prospectively followed.

You may qualify if:

• All patients with a post-injury open abdomen

You may not qualify if:

• 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.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Abdominal Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Clay Cothren Burlew, MD

  Denver Health and Hospital Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: May 15, 2013
• Study Start: January 1, 2013
• Primary Completion: June 29, 2022
• Study Completion: June 29, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

US (1)