Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-02-13 @ 5:32 AM
Study NCT ID:
NCT02817295
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2016-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bariatric Surgeries in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-05', 'studyFirstSubmitDate': '2016-06-22', 'studyFirstSubmitQcDate': '2016-06-26', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of complications.', 'timeFrame': 'six months', 'description': 'data collection and analysis will be ended in six months. data will be collected from the medical records.'}, {'measure': 'Number of revisions', 'timeFrame': 'six months', 'description': 'data collection and analysis will be ended in six months. data will be collected from the medical records.'}, {'measure': 'Number of days of hospitalization', 'timeFrame': 'six months', 'description': 'data collection and analysis will be ended in six months. data will be collected from the medical records.'}, {'measure': 'Incidence of co-morbidities', 'timeFrame': 'six months', 'description': 'data collection and analysis will be ended in six months. data will be collected from the medical records.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'an examination of the different aspects of bariatric surgery in elderly in comparison with non-elderly patients.', 'detailedDescription': 'the study examines the success rate, complications, revisions, days of hospitalization and co-morbidities in elderly and in non-elderly patients that underwent bariatric surgery in our medical center'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients underwent baritaric surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nbariatric surgery\n\nExclusion Criteria:\n\nbelow 18 years old'}, 'identificationModule': {'nctId': 'NCT02817295', 'briefTitle': 'Bariatric Surgeries in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Assuta Medical Center'}, 'officialTitle': 'Bariatric Surgeries in Elderly', 'orgStudyIdInfo': {'id': '2015073'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'elderly', 'description': 'patients underwent bariatric surgery and are above 65 years old', 'interventionNames': ['Other: clinical measurements']}, {'label': 'non-elderly', 'description': 'patients underwent bariatric surgery and are below 65 years old', 'interventionNames': ['Other: clinical measurements']}], 'interventions': [{'name': 'clinical measurements', 'type': 'OTHER', 'description': 'follow up on the number of complications, revisions, hospitalization and co-morbidities', 'armGroupLabels': ['elderly', 'non-elderly']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'state': 'Israel', 'country': 'Israel', 'facility': 'Assuta Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assuta Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Surgery department', 'investigatorFullName': 'Sergio Gabriel Susmallian', 'investigatorAffiliation': 'Assuta Medical Center'}}}}