Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-29 @ 4:36 PM
Study NCT ID:
NCT06319157
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breast Q-satisfaction with back', 'timeFrame': '6 months', 'description': 'Patient satisfaction with the back, assessed using the Breast Q-satisfaction with back subscale.\n\n6 months after surgery, the doctor provided each patient with a Breast Q-satisfaction with back questionnaire, and asked the patient to fill in the questionnaire truthfully, and each questionnaire took 1-4 minutes to complete. Before each questionnaire is completed, the doctor will give the patient a simple guide to make it clear what each option means.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '6 months', 'description': 'Other aspects of patient satisfaction, assessed using the Breast Q scale. 6 months after surgery, the doctor provided each patient with a questionnaire and asked the patient to fill it out truthfully, each questionnaire takes 1-4 minutes to complete, and a complete BREAST-Q survey can be completed in 10-15 minutes. Before each questionnaire is completed, the doctor will give the patient a simple guide to make it clear what each option means.'}, {'measure': 'Latissimus dorsi acquisition time', 'timeFrame': 'Perioperative', 'description': 'Calculated from the start of latissimus dorsi acquisition to the completion of latissimus dorsi acquisition.'}, {'measure': 'Intraoperative blood loss', 'timeFrame': 'Perioperative', 'description': 'The amount of blood lost by the patient due to routine operations during surgery.'}, {'measure': 'Postoperative pain', 'timeFrame': 'Perioperative', 'description': 'recorded using the Visual Analogue Scale (VAS) pain assessment tool.'}, {'measure': 'Postoperative complications', 'timeFrame': '6 months', 'description': 'including but not limited to surgical site infection, bleeding, wound dehiscence, breast/donor site flap/NAC necrosis, subcutaneous effusion in the chest and donor site, surgical side lymphedema, etc., are classified using the Clavien-Dindo grading system.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'For patients refusing implants for breast reconstruction after cancer surgery, autologous tissue flap reconstruction using the latissimus dorsi muscle is an alternative. Conventional surgery leaves a long incision on the back, affecting aesthetics and quality of life. Minimal access techniques result in a smaller, more concealable scar. While previous studies suggest its safety and effectiveness, most are retrospective. To further validate patient satisfaction and short-term outcomes, a prospective, randomized controlled trial comparing minimal access with conventional surgery is planned. The primary endpoint is Breast Q-satisfaction with back score at 6 months. Secondary outcomes include other Breast Q subscales, surgical metrics, and complications. The study aims to enroll 94 patients in total, providing evidence for surgical decision-making in breast cancer reconstruction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Female patients with early-stage breast cancer between the ages of 18 and 70.\n2. Breast cancer was confirmed by histology or biopsy.\n3. Breast-conserving surgery or multifocal breast cancer or large unifocal breast cancer (\\<5cm) can be accepted.\n4. After neoadjuvant therapy, large monofocal carcinoma (\\>5 cm) confined to the breast shrunk to \\<5 cm.\n5. No chest wall, cutaneous or NAC invasion (including Paget's disease).\n6. Mild to moderate breast sagging, and the patient has the willingness to undergo autologous reconstruction of the latissimus dorsi.\n7. There is no need to obtain additional back skins.\n8. Willing to participate and able to complete follow-up and evaluation during the study.\n\nExclusion Criteria:\n\n1. Patients with advanced breast cancer (stage III and above) or metastatic breast cancer or inflammatory breast cancer.\n2. The risk of recurrence is expected to be high.\n3. History of thoracic and dorsal vascular injury.\n4. Patients with severe heart, lung, or liver disease who cannot withstand surgery and anesthesia.\n5. Patients with active infection or severe immune system disease.\n6. Patients with severe allergic reactions to materials related to latissimus dorsi muscle flap transplantation.\n7. Patients with other major surgeries or reconstructive surgeries planned for the near future.\n8. Patients with cognitive dysfunction or psychiatric disorders who cannot understand and cooperate with the requirements of the study.\n9. Patients who refuse to participate in the study or are unable to complete follow-up and evaluation during the study."}, 'identificationModule': {'nctId': 'NCT06319157', 'briefTitle': 'Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'A Randomized Controlled Study of Minimal Access Latissimus Dorsi Flap Harvest for Breast Reconstruction Versus Conventional Approaches in the Treatment of Early Breast Cancer', 'orgStudyIdInfo': {'id': 'SYSKY-2023-1263-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'minimal access group', 'interventionNames': ['Device: minimal access breast reconstruction with a latissimus dorsi muscle flap']}, {'type': 'OTHER', 'label': 'conventional group', 'interventionNames': ['Device: conventional breast reconstruction with a latissimus dorsi muscle flap']}], 'interventions': [{'name': 'minimal access breast reconstruction with a latissimus dorsi muscle flap', 'type': 'DEVICE', 'description': 'minimal access breast reconstruction with a latissimus dorsi muscle flap', 'armGroupLabels': ['minimal access group']}, {'name': 'conventional breast reconstruction with a latissimus dorsi muscle flap', 'type': 'DEVICE', 'description': 'conventional breast reconstruction with a latissimus dorsi muscle flap', 'armGroupLabels': ['conventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shicheng Su, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'lnl_trial@126.com', 'phone': '+86 13632394954'}, {'name': 'Erwei Song, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'lnl_trial@126.com', 'phone': '+86 13719237746'}], 'facility': 'Sun Yat-sen Memorial Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Shicheng Su', 'role': 'CONTACT', 'email': 'sushch@mail.sysu.edu.cn', 'phone': '+8613631304227'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}