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Recruiting NCT07037537

Evaluation of the Effectiveness and Safety of Laparoscopic Assisted Mastectomy With Preservation of Nipple and Areola, Immediate One-step Breast Reconstruction With Pectoral Muscle Prosthesis and Patch, and Simultaneous Autologous Fat Transplantation

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Trial Parameters

Condition Breast Cancer Patients
Sponsor Henan Cancer Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 26
Sex FEMALE
Min Age 18 Years
Max Age 70 Years
Start Date 2024-10-30
Completion 2025-11
Interventions
Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation

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Brief Summary

Evaluation of the effectiveness and safety of laparoscopic assisted breast resection with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch for immediate one-step breast reconstruction and concurrent autologous fat transplantation in a prospective study

Eligibility Criteria

Inclusion Criteria: 1. Women aged 18 to 70 years old; 2. In the first diagnosis of unilateral breast cancer patients, the maximum diameter of invasive tumor is ≤ 5cm, and there is no requirement for tumor size of carcinoma in situ in principle; 3. Patients undergoing preventive mastectomy are not allowed to be included in the study; 4. Clinical examination and auxiliary examinations suggest that the tumor is confined to the mammary gland and has not invaded the nipple areola complex, skin, or chest wall; 5. Clinical axillary lymph node negative (clinical physical examination and imaging suggest negative axillary lymph nodes; for suspected positive axillary lymph nodes, fine needle aspiration or hollow needle biopsy is required to confirm negative); 6. Sentinel lymph node biopsy negative; 7. Patients with low load positive axillary lymph nodes (isolated tumor cells, micro or macro metastases), but exempted from adjuvant radiotherapy after surgery; 8. Patients who are not suitable for br

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