Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-29 @ 4:15 PM
Study NCT ID:
NCT04526561
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2020-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 550}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2020-08-12', 'studyFirstSubmitQcDate': '2020-08-24', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Validation of Breast Q: The Back Appearance scale for Swedish', 'timeFrame': '1 year', 'description': 'Translation and validation of the instrument for Swedish'}, {'measure': 'Validation of Breast-Q: The back and shoulder function scale for Swedish', 'timeFrame': '1 year', 'description': 'Translation and validation of the instrument for Swedish'}, {'measure': 'Normal material for Breast-Q', 'timeFrame': '5 years', 'description': 'Measurement of quality of life according to breast-Q in a normative population'}, {'measure': 'Normal material for Breast-Q back appearance scale', 'timeFrame': '5 years', 'description': 'Measurement of quality of life according to breast-Q back appaearance scale in a normative population'}, {'measure': 'Normal material for Breast-Q back and shoulder function scale', 'timeFrame': '5 years', 'description': 'Measurement of quality of life according to breast-Q back and shoulder function scale in a normative population'}], 'primaryOutcomes': [{'measure': 'Patient satisfaction and breast-related quality of life after breast reconstruction', 'timeFrame': '10 years', 'description': 'Breast Q reconstruction.The BREAST-Q has multiple domains, each scored from 0 to 100 (higher scores indicate greater satisfaction or quality of life), there is no overall BREAST-Q score.'}, {'measure': 'Back and shoulder function after breast reconstruction', 'timeFrame': '10 years', 'description': 'Breast Q the back and shoulder function scale. The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.'}, {'measure': 'Back appearance after breast reconstruction', 'timeFrame': '10 years', 'description': 'Breast-Q the back appearance scale.The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.'}, {'measure': 'Shoulder function after breast reconstruction', 'timeFrame': '10 years', 'description': 'Western Ontario Osteoarthritis of the shoulder index (WOOS) provides scores on four domains: (1) physical symptoms; (2) sport, recreation, and work; (3) lifestyle; and (4) emotions.Each question has a possible score from 0-100 giving a total score up to 1900. The highest or most symptomatic score is 1900 and the best or asymptomatic score is 0.'}, {'measure': 'Abdominal satisfaction after breast reconstruction', 'timeFrame': '10 years', 'description': 'Breast Q abdominal satisfaction and abdominal well-being.The scale is scored from 0 (worst) to 100'}], 'secondaryOutcomes': [{'measure': 'Complications after breast reconstruction', 'timeFrame': '2 years', 'description': 'Measured in patients randomized to TDAP or latissimus dorsi flap.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34217326', 'type': 'RESULT', 'citation': 'Kamya L, Hansson E, Weick L, Hansson E. Validation and reliability testing of the Breast-Q latissimus dorsi questionnaire: cross-cultural adaptation and psychometric properties in a Swedish population. Health Qual Life Outcomes. 2021 Jul 3;19(1):174. doi: 10.1186/s12955-021-01812-x.'}]}, 'descriptionModule': {'briefSummary': 'The latissimus dorsi flap is the oldest and most used technique for breast reconstruction. Nonetheless, there are few studies evaluation the long-term effect of harvesting one of the muscles of the back. This project has four parts.\n\n1. Validation of scales/instrument for Swedish.\n2. Long-term results after reconstruction with latissimus dorsi- a ten year retrospective follow-up.\n3. Thoracodorsal artery perforator flap (TDAP) vs latissimus dorsi flap- a randomized controlled trial - breast reconstruction.\n4. TDAP vs Limber flap - a randomized controlled trial- reconstruction of axillary hidradenitis suppurativa.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Biological women identifying themselves as cis-women.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients eligible for breast reconstruction following mastectomy and radiation\n* Non-smokers or ex-smokers (\\>6 weeks)\n* BMI \\< 30\n\nExclusion Criteria:\n\n* Inability to leave informed consent\n* Inability to understand Swedish\n* Previous surgery with scaring on back'}, 'identificationModule': {'nctId': 'NCT04526561', 'briefTitle': 'Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales', 'orgStudyIdInfo': {'id': '254-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Breast reconstruction TDAP', 'description': 'Breast reconstruction performed with TDAP', 'interventionNames': ['Procedure: Thoracodorsal artery perforator flap to breast']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Breast reconstruction latissimus dorsi', 'description': 'Breast reconstruction performed with latissimus dorsi', 'interventionNames': ['Procedure: Latissimus dorsi flap']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Breast reconstruction with DIEP', 'description': 'Breast reconstruction performed with a deep inferior epigastric artery perforator flap', 'interventionNames': ['Procedure: Deep inferior epigastric perforator flap']}], 'interventions': [{'name': 'Latissimus dorsi flap', 'type': 'PROCEDURE', 'otherNames': ['LD flap'], 'description': 'Breast reconstruction', 'armGroupLabels': ['Breast reconstruction latissimus dorsi']}, {'name': 'Thoracodorsal artery perforator flap to breast', 'type': 'PROCEDURE', 'otherNames': ['TDAP'], 'description': 'Breast reconstruction', 'armGroupLabels': ['Breast reconstruction TDAP']}, {'name': 'Deep inferior epigastric perforator flap', 'type': 'PROCEDURE', 'otherNames': ['DIEP flap'], 'description': 'Breast reconstruction', 'armGroupLabels': ['Breast reconstruction with DIEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska university hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}