Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT05664360
Status:
COMPLETED
Last Update Posted:
2022-12-23
First Post:
2022-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Outcomes of Emergency Department Patients Requiring Emergency General Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000375', 'term': 'Aging'}], 'ancestors': [{'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310914}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-17', 'studyFirstSubmitDate': '2022-12-09', 'studyFirstSubmitQcDate': '2022-12-17', 'lastUpdatePostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of emergency general surgery', 'timeFrame': 'Day 3', 'description': 'Emergency general surgery following ED visit'}], 'secondaryOutcomes': [{'measure': 'Admission to intensive care unit rate', 'timeFrame': 'During index hospitalization', 'description': 'Admission to intensive care unit'}, {'measure': 'ICU length of stay', 'timeFrame': 'During index hospitalization', 'description': 'Number of days spent in the ICU during hospital stay'}, {'measure': '30-day mortality rate', 'timeFrame': '30 days', 'description': '30-day mortality'}, {'measure': '90-day mortality rate', 'timeFrame': '90 days', 'description': '90-day mortality'}, {'measure': 'One-year mortality rate', 'timeFrame': 'One year', 'description': 'One-year mortality'}, {'measure': 'Hospital length of stay', 'timeFrame': 'During index hospitalization', 'description': 'Hospital length of stay'}, {'measure': 'Rate of patient dependent at discharge', 'timeFrame': 'Hospital discharge', 'description': 'Dependent at discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergency General Surgery']}, 'referencesModule': {'availIpds': [{'url': 'https://www.doi.org/10.17605/OSF.IO/TRU4N', 'type': 'Individual Participant Data Set'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study were (1) to estimate the incidence of emergency general surgery in a Swiss University Hospital, (2) to describe the characteristics and outcomes of patients undergoing such interventions, and (3) to study the impact of age on the outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients visiting the emergency department', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- consecutive patients visiting the emergency department\n\nExclusion Criteria:\n\n* admitted primarily for a psychiatric reason\n* left without consultation'}, 'identificationModule': {'nctId': 'NCT05664360', 'briefTitle': 'Incidence and Outcomes of Emergency Department Patients Requiring Emergency General Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Incidence and Outcomes of Emergency Department Patients Requiring Emergency General Surgery', 'orgStudyIdInfo': {'id': 'EGS1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ED patients', 'interventionNames': ['Other: Age (young versus older)']}], 'interventions': [{'name': 'Age (young versus older)', 'type': 'OTHER', 'description': 'Age', 'armGroupLabels': ['ED patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christophe A Fehlmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Genava University Hospitals'}]}, 'ipdSharingStatementModule': {'url': 'https://www.doi.org/10.17605/OSF.IO/TRU4N', 'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': 'As soon as published', 'ipdSharing': 'YES', 'accessCriteria': 'Without restriction'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christophe Fehlmann', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}