Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-03 @ 4:48 AM
Study NCT ID:
NCT03209167
Status:
COMPLETED
Last Update Posted:
2017-07-06
First Post:
2017-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Patient Satisfaction of the Abdomen After DIEAP Procedure and Conventional Abdominoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2004-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-03', 'studyFirstSubmitDate': '2017-07-03', 'studyFirstSubmitQcDate': '2017-07-03', 'lastUpdatePostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2004-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing patient satisfaction of the abdomen after DIEAP procedure and conventional abdominoplasty', 'timeFrame': '2001 to 2004.', 'description': 'The purpose of this study was to specifically compare the long term patient satisfaction of the abdomen after DIEAP flap procedure with conventional abdominoplasty.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast reconstruction; abdominoplasty; patient satisfaction'], 'conditions': ['Donor Site Complication', 'Satisfaction, Personal', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to specifically compare the long term patient satisfaction of the abdomen after DIEAP flap procedure with conventional abdominoplasty.', 'detailedDescription': '34 patients reconstructed with a DIEAP flap (DIEAP group) and 30 patients who had undergone a conventional abdominoplasty (AP group) were asked to complete two study-specific questionnaires. One questionnaire covered general and specific aspects concerning abdominal outcomes and morbidity. The other covered general outcomes such as satisfaction with surgery and change of body image, self-confidence, social and intimate relations. In addition, all patients performed an abdominal muscle function test.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral DIEAP flap, abdominoplasty\n\nExclusion Criteria:\n\n* bilateral DIEAP flap, progressive cancer disease'}, 'identificationModule': {'nctId': 'NCT03209167', 'briefTitle': 'Comparing Patient Satisfaction of the Abdomen After DIEAP Procedure and Conventional Abdominoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Comparing Patient Satisfaction of the Abdomen After DIEAP Procedure and Conventional Abdominoplasty', 'orgStudyIdInfo': {'id': 'OsloPlastic'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DIEAP group', 'description': 'Patients who had undergone DIEAP flap breast reconstruction', 'interventionNames': ['Behavioral: Questionnaire']}, {'label': 'AP group', 'description': 'Patients who had undergone conventional abdominoplasty', 'interventionNames': ['Behavioral: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'description': 'Two study-specific questionnaires', 'armGroupLabels': ['AP group', 'DIEAP group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of division', 'investigatorFullName': 'Kim Alexander Tønseth', 'investigatorAffiliation': 'Oslo University Hospital'}}}}