Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-30 @ 6:38 AM
Study NCT ID:
NCT04725968
Status:
COMPLETED
Last Update Posted:
2021-03-24
First Post:
2021-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Morbimortality in Major Urgent General Surgery in the Geriatric Patient.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2021-01-16', 'studyFirstSubmitQcDate': '2021-01-21', 'lastUpdatePostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of complications', 'timeFrame': '30 days after surgery', 'description': 'Evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale).'}, {'measure': 'Mortality rate', 'timeFrame': '1 year', 'description': 'Global mortality and mortality after: 30 days, 6 months and 1 year.'}], 'secondaryOutcomes': [{'measure': 'Days of admission', 'timeFrame': '30 days after surgery'}, {'measure': 'days in ICU/Reanimation', 'timeFrame': '30 days after surgery'}, {'measure': 'NELA Risk Score', 'timeFrame': 'pre-surgery', 'description': '"National Emergency Laparotomy Audit" % of death'}, {'measure': 'NSQUIP Risk Score', 'timeFrame': 'pre-surgery', 'description': '"American College of Surgeons National Surgical Quality Improvement Program": % of death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery--Complications', 'Emergencies']}, 'descriptionModule': {'briefSummary': 'Retrospective observational cohort study of geriatric patients operated of urgent major general surgery in our centre during 2018.\n\nOur principal goals are:\n\n1. To evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale)\n2. To evaluate the mortality: global mortality and mortality after: 30 days, 6 months and 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the geriatric patients operated of urgent major general surgery in our centre during 2018.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgeries on the small and / or large bowel with or without intestinal resection, total colectomies, exploratory laparotomies\n\nExclusion Criteria:\n\n* Polytraumatic patient, reoperations (for any cause) of scheduled and urgent surgeries'}, 'identificationModule': {'nctId': 'NCT04725968', 'briefTitle': 'Morbimortality in Major Urgent General Surgery in the Geriatric Patient.', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Morbimortality in Major Urgent General Surgery in the Geriatric Patient. Observational Study of Retrospective Cohort.', 'orgStudyIdInfo': {'id': 'IIBSP-CGM-2020-108'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Urgent major general surgery', 'type': 'PROCEDURE', 'description': 'All geriatric patients (75 years and over) going under urgent major general surgery during 2018 in our centre'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}