Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-18 @ 11:29 AM
Study NCT ID:
NCT02532751
Status:
UNKNOWN
Last Update Posted:
2018-02-22
First Post:
2015-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Body Contouring Surgery in Obese Patients
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': '2018-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-21', 'studyFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2015-08-23', 'lastUpdatePostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of the Finnish version of the BODY-Q questionnaire', 'timeFrame': '6 months', 'description': 'The psychometric properties of the BODY-Q patient-reported outcome measure are measured'}, {'measure': 'Health-related quality of life after body contouring surgery in obese patients', 'timeFrame': '0.5 to 3 years', 'description': 'Health-related quality of life is assessed with a questionnaire'}, {'measure': 'Depression after body contouring surgery in obese patients', 'timeFrame': '0.5 to 3 years', 'description': 'Depression is assessed with a questionnaire'}, {'measure': 'Body image after body contouring surgery in obese patients', 'timeFrame': '0.5 to 3 years', 'description': 'Body image is assessed with a questionnaire'}], 'secondaryOutcomes': [{'measure': 'The 15-Dimensions health-related quality of life instrument', 'timeFrame': '0.5 to 3 years', 'description': 'Assessment of health-related quality of life'}, {'measure': 'The BODY-Q questionnaire', 'timeFrame': '0.5 to 3 years', 'description': 'Assessment of health-related quality of life and body image'}, {'measure': 'The Raitasalo Beck Depression Index questionnaire', 'timeFrame': '0.5 to 3 years', 'description': 'Assessment of depression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Validation Study', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The aim of this study is twofold; 1) to assess the psychometric properties of the Finnish version of the BODY-Q questionnaire, 2) to assess the effects of body contouring surgery using patient-reported outcome measures.', 'detailedDescription': 'The BODY-Q is translated into Finnish through forward and backward translation and a committee review. The preliminary version is pilot tested with 20 participants undergoing body contouring surgery.\n\nThe study is of longitudinal design gathering data from participants undergoing body contouring surgery due to obesity. Data collection takes place in the Department of Plastic Surgery, Helsinki University Central Hospital, Helsinki, Finland. The participants fill in three patient-reported outcome measures.\n\nThe outcomes of the three patient-reported outcome measures are compared with each other and internal validity assessed. Test-retest reliability is assessed after two weeks from the first completion of the questionnaires. With validated questionnaires the effects of body contouring surgery is assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100 patients who underwent body contour surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body contouring surgery due to:\n\nA) massive weight loss B) Postbariatric weight loss\n\n* Patient age over 18 years\n\nExclusion Criteria:\n\n* Patient age under 18 years\n* No body contouring surgery\n* Surgical intervention performed in another hospital than Helsinki and Uusimaa Hospital District\n* No obesity'}, 'identificationModule': {'nctId': 'NCT02532751', 'briefTitle': 'Effects of Body Contouring Surgery in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Effects of Body Contouring Surgery in Obese Patients: a Prospective Study', 'orgStudyIdInfo': {'id': '204/13/03/02/15/1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Espoo', 'state': 'Uusimaa', 'country': 'Finland', 'contacts': [{'name': 'Tiina Jahkola, MD, PhD', 'role': 'CONTACT'}, {'name': 'Pauliina Homsy, MD, PhD (Cantab)', 'role': 'CONTACT'}], 'facility': 'Jorvi Central Hospital', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}, {'zip': '00029', 'city': 'Helsinki', 'state': 'Uusimaa', 'country': 'Finland', 'contacts': [{'name': 'Jussi P Repo, MD', 'role': 'CONTACT', 'email': 'mrjussirepo@gmail.com', 'phone': '+358443593100'}, {'name': 'Jussi P Repo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pentscho Popov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Jussi P Repo, MD', 'role': 'CONTACT', 'email': 'mrjussirepo@gmail.com', 'phone': '+358443593100'}, {'name': 'Pentscho Popov, MD, PhD', 'role': 'CONTACT', 'email': 'pentscho.popov@hus.fi', 'phone': '+35894711'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jussi Repo', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}