Breast reconstruction surgery
Conditions
Interventions
Sponsors
Fudan University Cancer Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged >=18 years old; 2. Patients with unilateral breast cancer, and the maximum diameter of the tumor is <= 5cm; 3. Clinical axillary lymph node (ALN) negative (clinical physical examination and ultrasound revealed negative axillary lymph nodes; clinically suspicious axillary lymph nodes, fine needle aspiration or core needle biopsy results are negative); 4. Patients who intend to undergo mastectomy (SSM/NSM) with skin or nipple and areola preserving and need to use prosthesis and patch for immediate breast reconstruction; 5. No smoking history or quit smoking for more than 4 weeks (inclusive); 6. After obtaining full knowledge, voluntarily participate and sign the "Informed Consent".
Exclusion criteria
Exclusion criteria: 1. Patients with moderate to severe breast sagging; 2. Patients who have received radiotherapy at the reconstruction site or chest wall and/or are expected to undergo radiotherapy after surgery; 3. Patients who have received neoadjuvant therapy; 4. Plan to perform symmetrical breast surgery on the healthy side of the breast during the visit period; 5. Expected implanted breast prosthesis volume> 500ml; 6. Suffer from poorly controlled diabetes, severe heart disease, heart failure or severe liver and kidney dysfunction/blood system diseases and other serious systemic diseases; 7. People with mental illness or mental abnormality; 8. Patients who are pregnant, breastfeeding or planning to conceive during the study period; 9. Participating in other clinical trials, which may affect participation in this trial; 10. Poor compliance, unable to carry out relevant inspections and follow-ups in accordance with the test requirements; 11. Other patients who have been judged by the investigator to be unsuitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breast reconstruction success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complications;Breast-Q (breast reconstruction module) score changes;Evaluation of Aesthetic Effect of Breast Reconstruction; | — |
Countries
China
Contacts
Public ContactWu Jiong
Fudan University Cancer Hospital
Outcome results
None listed