Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT04536818
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2020-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes After Laparotomy for Penetrating Abdominal Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007813', 'term': 'Laparotomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-27', 'studyFirstSubmitDate': '2020-08-21', 'studyFirstSubmitQcDate': '2020-08-27', 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': 'Through study completion, an average of 2 weeks', 'description': 'In-hospital death.'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'Through study completion, an average of 2 weeks', 'description': 'Complications according to the Clavien-Dindo classification.'}, {'measure': 'Length of stay', 'timeFrame': 'Through study completion, an average of 2 weeks', 'description': 'Length of hospital stay.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Penetrating Abdominal Trauma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate outcomes of adult patients hospitalised due to penetrating abdominal trauma at a tertiary trauma hospital in South Africa. Our primary objective is to study the association between waiting time to surgery and outcome (mortality, complications, and length of hospital stay) in normotensive patients treated with laparotomy for penetrating abdominal trauma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to Tygerberg Academic Hospital, Cape Town, South Africa.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that are admitted due to penetrating abdominal injuries, irrespective of injury mechanism, time from injury and prior treatment.\n* Patients that are treated with laparotomy.\n\nExclusion Criteria:\n\n* Patients that are admitted due to blunt trauma or combinations of blunt and penetrating trauma.\n* Patients who are dead on arrival.\n* Patients that are only re-admitted during the study period, i.e. patients that received primary treatment by TBH before study initiation.'}, 'identificationModule': {'nctId': 'NCT04536818', 'briefTitle': 'Outcomes After Laparotomy for Penetrating Abdominal Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Outcomes After Laparotomy for Penetrating Abdominal Trauma: A Cohort Study From a Tertiary Trauma Hospital in South Africa', 'orgStudyIdInfo': {'id': 'TraumaLapCohort'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Time to surgery ≤12 hours', 'description': 'Waiting time to surgery ≤12 hours from hospital presentation.', 'interventionNames': ['Procedure: Laparotomy']}, {'label': 'Time to surgery >12 hours', 'description': 'Waiting time to surgery \\>12 hours from hospital presentation.', 'interventionNames': ['Procedure: Laparotomy']}], 'interventions': [{'name': 'Laparotomy', 'type': 'PROCEDURE', 'description': 'Exploratory laparotomy.', 'armGroupLabels': ['Time to surgery >12 hours', 'Time to surgery ≤12 hours']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Tygerberg Academic Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Stellenbosch', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andreas Älgå', 'investigatorAffiliation': 'Karolinska Institutet'}}}}