Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04343820
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-07
First Post:
2020-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation (RM2prepec)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016462', 'term': 'Mammaplasty'}], 'ancestors': [{'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-12-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2020-04-10', 'studyFirstSubmitQcDate': '2020-04-10', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe the complications that occurs after a prepectoral placed implant with lipo-preparation', 'timeFrame': '12 months', 'description': 'Pre-surgical implant positioning failure at 12 months. A failure will be defined by the occurence of at least one of the following complications : documented infection ; red breast syndrome ; hematoma ; lymphocele ; delayed healing ; prothesis removal ; stage 1 hull (Baker classification) ; prothesis rotation ; waves / folds ; muscle contractions with prothesis animation ; pain (EVA 4 or 5)'}], 'secondaryOutcomes': [{'measure': 'Evaluate the aesthetic result', 'timeFrame': '6 months, 12 months and 24 months', 'description': 'Aesthetic result will be assessed by giving a mark from 0 to 5 for the following categories : general breast appearance ; breast curve ; breast consistency ; breast volume Both clinician and patient will complete the evaluation.'}, {'measure': 'Evaluate the quality of life', 'timeFrame': '24 months', 'description': 'Patient satisfaction and quality of life will be assessed from Breast Q. The evaluation criteria will be the Breast Q score 24 months after the intervention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['reconstruction', 'lipo-modelling', 'breast cancer', 'mastectomy', 'prepectoral implant'], 'conditions': ['Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'Breast implants associated with the installation of a complementary matrix (of dermal or synthetic origin), showed satisfactory results in term of post-operative follow-up but also aesthetic outcomes.\n\nThe objective of the subcutaneous positioning of this implant, is to reduce the muscular pain related to the stretching of the muscular muscle, the deformations related to the muscular contraction with an animation of the prothesis, but also the risk of hull when associated with a matrix. It also pursues the objective, of obtaining a better aesthetic result, by systematically coupling at least one lipo-modelling session.\n\nFor a long time, patients with a history of mastectomy and radiotherapy benefited from secondary breast flap reconstruction, in order to reduce the risk of complications and achieve a satisfying aesthetic outcome. But the lipo-filling technique allowed to reconsider the management of these patients.\n\nThe benefits of fat tissue transplants are know to improve tissue trophicity (flexibility, thickness, vascularization).\n\nThe objective of this study, is to evaluate the feasibility of secondary breast reconstructions by prepectoral positioned implant after lipo-preparation of the wall.', 'detailedDescription': "60 women who have had a mastectomy and want a secondary breast reconstruction by implant at Institut de Cancérologie de l'Ouest well be included in this study.\n\nPatients will be recruited in consultation before the start of reconstruction and up to 18 months after radiation therapy.\n\nThey will be followed for 24 months from the end of the breast reconstruction.\n\nThe following data will be collected indirectly from the clinical medical record (letters, reports of examinations, consultations, surgical report, hospitalization) of the patient, supplemented if necessary by specific records (radiotherapy records, chemotherapy, physiotherapy management) :\n\n* Clinical data\n* Technique-related data\n* Complication-related data : adverse events will be evaluated at 15 days, 3 months, 6 months, 12 months and 24 months after reconstruction\n* Aesthetic results data : aesthetic result will be evaluated by patients and surgeons at 6 months, 12 months and 24 months after reconstruction\n* Quality of life data : a questionnaire will be submitted prior to the intervention, at 12 months and 24 months after reconstruction\n\nClinicians at Institut de Cancérologie de l'Ouest may be asked to complete the previous informations."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study concerns women who have had a mastectomy and want a secondary breast reconstruction by implant.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman aged over 18\n* Medical history of mastectomy +/- radiotherapy\n* Woman requesting breast reconstruction by implant\n* Patient treated for non-metastatic cancer\n\nExclusion Criteria:\n\n* Locally uncontrolled disease\n* Metastatic disease\n* Patient with major cutaneous atrophy allowing only flap reconstruction\n* Patients under guardianship or trusteeship\n* Patients who objected to the research'}, 'identificationModule': {'nctId': 'NCT04343820', 'acronym': 'RM2prepec', 'briefTitle': 'Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation (RM2prepec)', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation : Feasibility, Complications, Evaluation of Aesthetic Result and Quality of Life.', 'orgStudyIdInfo': {'id': 'ICO-N-2018-15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast reconstruction', 'description': 'Women who have had a mastectomy and want a secondary breast reconstruction by implant.', 'interventionNames': ['Procedure: Breast reconstruction']}], 'interventions': [{'name': 'Breast reconstruction', 'type': 'PROCEDURE', 'description': 'Breast reconstruction by prepectoral positioned implant after lipo-preparation of the wall.', 'armGroupLabels': ['Breast reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': "Institut de Cancérologie de l'Ouest René Gauducheau", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}], 'overallOfficials': [{'name': 'Victoire BRILLAUD-MEFLAH, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut de Cancérologie de l'Ouest"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}