Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT02962193
Status:
UNKNOWN
Last Update Posted:
2016-11-11
First Post:
2016-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Functional and Social Changes After Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-10', 'studyFirstSubmitDate': '2016-11-06', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of participation before and after surgery', 'timeFrame': 'the patient will answer the questionnaire before and after (3 months, 6 months) surgery.'}], 'secondaryOutcomes': [{'measure': 'sexuality questionnaire', 'timeFrame': 'the patient will answer the questionnaire before and after (3 months, 6 months) surgery.'}, {'measure': 'activity daily questionnaire', 'timeFrame': 'the patient will answer the questionnaire before and after (3 months, 6 months) surgery.'}, {'measure': 'range of motion (flexion of knee and thigh in degrees)', 'timeFrame': 'measure will be taken before and after (3 months, 6 months) surgery.'}, {'measure': 'circumferences mesurement (knee, thigh and waist) in centimeters', 'timeFrame': 'measure will be taken before and after (3 months, 6 months) surgery.'}]}, 'conditionsModule': {'keywords': ['ADL', 'Bariatric surgery', 'Daily participation'], 'conditions': ['Functional and Social Performance']}, 'descriptionModule': {'briefSummary': 'After bariatric surgery there are big changes in the daily functions, activities and social participation of the patients.\n\nThis is a prospective study that examine daily performance and daily participation by questionnaires, before and after bariatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Overweight patients who are fit for surgery .', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight patients who are fit for surgery .\n\nExclusion Criteria:\n\n* Children, Neurological patients, amputations'}, 'identificationModule': {'nctId': 'NCT02962193', 'briefTitle': 'Evaluation of Functional and Social Changes After Bariatric Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Western Galilee Hospital-Nahariya'}, 'officialTitle': 'Evaluation of Functional and Social Changes After Bariatric Surgery', 'orgStudyIdInfo': {'id': '0043-16-NHR'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Galilee Hospital-Nahariya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Farraj Moaad', 'investigatorAffiliation': 'Western Galilee Hospital-Nahariya'}}}}