Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-03 @ 7:20 PM
Study NCT ID:
NCT05527769
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2022-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008408', 'term': 'Mastectomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe postoperative pain and functional results', 'timeFrame': '6 month', 'description': 'Brief Pain Inventory (BPI) short form - 4 scales from 1 (No pain) to 10 (max pain) + 7 scales from 1 (no discomfort) to 10 (max discomfort) to determine if the pain interfered with activities of daily living'}], 'secondaryOutcomes': [{'measure': 'Assessing quality of life and aesthetic satisfaction', 'timeFrame': '6 months', 'description': 'breast questionary pre-post operative reconstruction module'}, {'measure': 'Evaluate the function of the homolateral upper limb', 'timeFrame': '6 months', 'description': 'Disabilities of the Arm, Shoulder and Hand self-assessment'}, {'measure': 'Describe the occurrence of postoperative complications', 'timeFrame': '3 months', 'description': 'postoperative complications'}, {'measure': 'Describe the length of operative stay (for the initial reconstruction), for all patients and according to the methods of reconstruction performed', 'timeFrame': '3 months', 'description': 'duration of hospitalization'}, {'measure': 'Describe the duration of drainage for all patients and according to the methods of reconstruction performed', 'timeFrame': '3 months', 'description': 'duration of drainage in the breast and back, number of punctures and total volume of seroma punctures (classification \\<2)'}, {'measure': 'Describe the number of surgery(s) required to obtain a good aesthetic result', 'timeFrame': '3 months', 'description': 'number of surgery(s)'}, {'measure': 'Describe the number of consultations for seroma punctures, for all patients and according to the methods of reconstruction performed', 'timeFrame': '3 months', 'description': 'number of punctures and total volume of seroma punctures (classification \\<2)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-center, non-randomized study of immediate breast reconstruction (IBR) using a pre- or retro-pectoral technique in patients with breast cancer who have undergone total mastectomy.\n\nThe technique used is chosen according to the characteristics of the breast, the morphology of the patient and her wishes after informed information on the different techniques. The aim is not to compare the two techniques but rather to evaluate the early functional results of these two methods in order to better understand them and to propose a management adapted to each.\n\nThe main objective will be to evaluate the postoperative pain by BPI questionnaire.\n\nThe investigators also wish to observe the functional results of the homolateral upper limb by DASH questionnaire, the quality of life by BREAST Q questionnaire and the occurrence of complications.', 'detailedDescription': 'describe the occurrence of complications between pre-pectoral and retro-pectoral technique in patients with breast cancer who have total mastectomy.\n\nevaluate the postoperative pain by Brief Pain Inventory (BPI) self assesment observe the functional results of the homolateral upper limb by Disabilities of the Arm, Shoulder and Hand (DASH) self assesment observe quality of life by BREAST Q questionary'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Major patients followed for breast cancer with indication of mastectomy with immediate breast reconstruction by prosthesis.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Major patients\n2. With breast cancer and indication for total mastectomy\n3. With a desire for immediate breast reconstruction\n4. Total mastectomy procedure and Immediate Breast Reconstruction by Pre-pectoral or Retro-Pectoral prosthesis\n5. Information of the patient and collection of his/her non-opposition\n6. Affiliation with a social securitý scheme, or beneficiary of such a scheme\n\nExclusion Criteria:\n\n1. Prophylactic mastectomies\n2. Metastatic patients\n3. Patients requiring another surgical technique\n4. Person in an emergency situation, person of legal age under legal protection (adult under guardianship, curators or safeguard of justice), or unable to express consent,\n5. Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons\n6. Pregnant or likely to be pregnant'}, 'identificationModule': {'nctId': 'NCT05527769', 'acronym': 'DREAM-RMI', 'briefTitle': 'Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Prospective Study Evaluating Postoperative Pain and Functional Recovery After Mastectomy and Immediate Breast Reconstruction by Implant: Prepectoral Versus Subpectoral Technique', 'orgStudyIdInfo': {'id': 'ICO-2021-36'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pre-pectoral prosthesis', 'description': 'breast cancer patients with an indication for total mastectomy + immediate breast reconstruction (IBR) by prosthesis using a pre-pectoral technique', 'interventionNames': ['Procedure: mastectomy + immediate breast reconstruction']}, {'label': 'retropectoral prosthesis', 'description': 'breast cancer patients with an indication for total mastectomy + immediate breast reconstruction (IBR) by prosthesis using the retropectoral technique', 'interventionNames': ['Procedure: mastectomy + immediate breast reconstruction']}], 'interventions': [{'name': 'mastectomy + immediate breast reconstruction', 'type': 'PROCEDURE', 'description': 'pre- or retro pectoral prosthesis', 'armGroupLabels': ['pre-pectoral prosthesis', 'retropectoral prosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': "Institut de Cancerologie de L'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}], 'overallOfficials': [{'name': 'Céline RENAUDEAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'celine.renaudeau@ico.unicancer.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}