Prepectoral and Subpectoral Implant-based Breast Reconstruction
Sponsored by Fudan University
About this trial
Last updated 4 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 3 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
1. More than 18 years old
2. Female
3. Preoperative pathology confirming invasive breast carcinoma or ductal carcinoma in situ
4. Clinical T1 and T2 (Maximum tumor diameter ≤5 cm)
5. Clinical ALN negative (Clinical physical examination and ultrasound indicate axillary lymph node negative; Suspected abnormality of axillary lymph node, and fine needle aspiration negative)
6. No clinical or imaging evidence of distant metastasis
7. Patients to receive skin sparing mastectomy or nipple sparing mastectomy
8. BMI < 35
9. Patients with no or mild mastoptosis
10. Prosthesis to be implanted <500 ml
11. Be able and willing to sign the Informed Consent Form (ICF)
Exclusion Criteria
1. Patients with the breast of moderate-severe mastoptosis, or requiring the use of Wise-pattern or other breast lift methods for subcutaneous mammary gland resection
2. BMI>=35
3. Patients who have received symmetrical breast surgery on the unaffected side immediately or later
4. Patients with locally advanced breast cancer to receive neoadjuvant therapy
5. Patients currently participating in other clinical trials, which may have impact on the participation in this trial
6. Neoadjuvant therapy has been completed, and there is clear indication of adjuvant radiotherapy after the operation
7. Previous history of breast cancer (patients with ipsilateral recurrence after breast sparing surgery)
8. Pregnancy breast-feeding women
9. History of smoking
10. Previous history of diabetes