Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT01853735
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2013-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enteral Feeding in the Post-Injury Open Abdomen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000007', 'term': 'Abdominal Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 515}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-19', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-05-09', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'infectious complications', 'timeFrame': 'participants will be followed for their hospital stay, which is on average expected to be 1 month', 'description': 'physical exam and imaging will be reviewed to assess infections'}], 'primaryOutcomes': [{'measure': 'fascial closure rate', 'timeFrame': 'participants will be followed for their hospital stay, which is on average expected to be 1 month', 'description': 'physical exam will document fascial closure'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'participants will be followed for their hospital stay, which is on average expected to be 1 month', 'description': 'subject mortality status'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Trauma to the Abdomen']}, 'descriptionModule': {'briefSummary': '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.\n\nSpecific aims:\n\nHypothesis 1: EN in patients with a traumatic bowel injury requiring an open abdomen improves fascial closure rate compared to patients who remain NPO.\n\nHypothesis 2: EN in patients with a traumatic bowel injury requiring an open abdomen reduces infectious complications compared to patients who remain NPO.\n\nHypothesis 3: EN in patients with a traumatic bowel injury requiring an open abdomen have a lower mortality rate compared to patients who remain NPO.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '98 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients requiring an open abdomen following trauma will be prospectively followed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with a post-injury open abdomen\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT01853735', 'briefTitle': 'Enteral Feeding in the Post-Injury Open Abdomen', 'organization': {'class': 'OTHER', 'fullName': 'Denver Health and Hospital Authority'}, 'officialTitle': 'Enteral Nutrition in the Open Abdomen', 'orgStudyIdInfo': {'id': '13-0077'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bowel injury, NPO', 'description': 'Patients with bowel injury who remain nil-per-os (fed nothing)'}, {'label': 'bowel injury, EN', 'description': 'Patients with bowel injury who are fed by enteral nutrition (EN)'}, {'label': 'no bowel injury, NPO', 'description': 'Patients without bowl injury who remain nil-per-os (fed nothing)'}, {'label': 'no bowel injury, EN', 'description': 'Patient without bowl injury who are fed by enteral nutrition (EN)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Clay Cothren Burlew, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Denver Health and Hospital Authority'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Denver Health and Hospital Authority', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Ryan Lawless', 'investigatorAffiliation': 'Denver Health and Hospital Authority'}}}}