Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:32 AM
Study NCT ID:
NCT07490158
Status:
RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enteric Anastomoses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number and Description of Study Sites', 'timeFrame': '5 years', 'description': 'This study will include all trauma patients at Methodist Dallas Medical Center diagnosed with traumatic colon injury and meets registry inclusion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trauma']}, 'descriptionModule': {'briefSummary': 'This retrospective data repository will serve as a means to aggregate and analyze best practices as relative to traumatic colon injury outcomes.', 'detailedDescription': 'The primary objective of this study is to establish a data repository that will be permissive of quality improvement studies/observations specific to traumatic colon injuries and evaluate current surgical management as treatment, specifically comparing initial primary anastomosis, delayed anastomosis, and ostomy diversion outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All trauma patients at Methodist Dallas Medical Center (MDMC) diagnosed with traumatic colon injury and meets registry inclusion', 'eligibilityCriteria': 'Inclusion Criteria:\n\n18 years old Included in the MDMC(Methodist Dallas Medical Center) Trauma Registry Any diagnosis code indicative of injury to the large and/or small bowel (S36.5 and/or S36.4)\n\nExclusion Criteria:\n\n\\<18 years old Prisoners, pregnant persons, or other protected population.'}, 'identificationModule': {'nctId': 'NCT07490158', 'briefTitle': 'Enteric Anastomoses', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Health System'}, 'officialTitle': 'Enteric Anastomoses in Trauma', 'orgStudyIdInfo': {'id': '051.TRA.2023.D'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Total Number and Description of Study Sites/Total Number of Subjects Projected', 'description': 'Include all trauma patients at Methodist Dallas Medical Center (MDMC) diagnosed with traumatic colon injury and meets registry inclusion. Enrollment will terminate once five years of data are captured: January 2018 through December 2023.', 'interventionNames': ['Other: Medical/Phenotype Data Collection Procedures & Data to be Collected']}], 'interventions': [{'name': 'Medical/Phenotype Data Collection Procedures & Data to be Collected', 'type': 'OTHER', 'description': 'The Methodist Dallas Medical Center Trauma Registry will be queried for demographic information, diagnosis codes, admission dates, traumatic injury characteristics, surgical procedures, comorbidities, inpatient outcomes, complications, consultations, discharge location, and mortality. Additional laboratory values will be abstracted from Epic through retrospective chart review.', 'armGroupLabels': ['Total Number and Description of Study Sites/Total Number of Subjects Projected']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Colette Ngo Ndjom', 'role': 'CONTACT', 'email': 'ClinicalResearch@mhd.com', 'phone': '214-947-1289'}, {'name': 'Kavya Mankulangara', 'role': 'CONTACT', 'email': 'ClinicalResearch@mhd.com', 'phone': '214-947-4604'}], 'facility': 'Methodist Dallas Medical Center- Clinical Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Crystee Cooper, DHEd', 'role': 'CONTACT', 'email': 'ClinicalResearch@mhd.com', 'phone': '214-947-1280'}, {'name': 'Kavya Mankulangara', 'role': 'CONTACT', 'email': 'ClinicalResearch@mhd.com', 'phone': '214-947-4604'}], 'overallOfficials': [{'name': 'Andrew Karpisek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Methodist Health System'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'All information will be blinded in compliance with Good Clinical Practice. The investigator will make all possible efforts to ensure compliance with all policies regarding sharing of protected health information or research information. Only de-identified protected health information will be shared in relevant research mediums.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}