Evaluation of the Effectiveness and Safety of Laparoscopic Assisted Mastectomy With Preservation … (NCT07037537) | Clinical Trial Compass
RecruitingNot Applicable
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
China26 participantsStarted 2024-10-30
Plain-language 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
Who can participate
Age range18 Years – 70 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Women aged 18 to 70 years old;
✓. 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;
✓. Patients undergoing preventive mastectomy are not allowed to be included in the study;
✓. 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;
✓. 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);
✓. Sentinel lymph node biopsy negative;
✓. Patients with low load positive axillary lymph nodes (isolated tumor cells, micro or macro metastases), but exempted from adjuvant radiotherapy after surgery;
✓. Patients who are not suitable for breast conserving surgery or who are unwilling to undergo breast conserving surgery and plan to undergo laparoscopic assisted mastectomy with preservation of the nipple and areola, as well as immediate one-step breast reconstruction with a breast prosthesis combined with a chest muscle prosthesis and simultaneous fat transplantation; If frozen pathology or routine pathology indicates a positive posterior margin of the nipple, it is allowed to remove the nipple, but the areola must be preserved;
Exclusion criteria
✕. Specialized physical examination and/or auxiliary examination suggest that the tumor involves the nipple areola complex (including Paget's disease) or the skin;
What they're measuring
1
Incidence of serious complications after breast reconstruction surgery
Timeframe: One week after surgery, one month after surgery, three months after surgery, six months after surgery, and one year after surgery
✕. Patients who have undergone fat injection, breast augmentation with implants, and breast reduction surgery in the past;
✕. Patients with incomplete immune function, poor control of diabetes and active smoking;
✕. Patients with severe breast sagging;
✕. Breast cup size ≥ E;
✕. Accept two-step breast reconstruction using dilators/prostheses, autologous breast reconstruction, and breast reconstruction performed through open surgery;