Breast Cancer, Breast Reconstruction
Conditions
Keywords
Endoscopic, Nipple-Sparing Mastectomy, Fat Grafting, Breast Reconstruction
Brief summary
The goal of this clinical study is to evaluate the effectiveness and safety of a novel breast reconstruction technique combining endoscopic nipple-sparing mastectomy (E-NSM) with immediate multistage fat grafting (IMFG) in female patients aged 18 years or older with clinical stage 0 to II breast cancer who desire immediate breast reconstruction. The main questions it aims to answer are: Does the combined E-NSM and IMFG approach improve patient-reported outcomes, including satisfaction with breasts and physical well-being, as measured by the BREAST-Q questionnaire? What is the frequency and nature of surgical complications associated with this technique, such as wound healing, hemorrhage, and need for reoperation? Participants will undergo endoscopic nipple-sparing mastectomy with lymph node surgery followed by immediate multistage fat grafting for total breast reconstruction via a small cosmetic axillary incision. They will also complete the BREAST-Q questionnaire and receive clinical and photography-based assessments at follow-up visits to evaluate aesthetic and quality-of-life outcomes.
Interventions
PROCEDUREendoscopic nipple-sparing mastectomy (E-NSM) with immediate implant-based reconstruction
The patient was positioned supine, with the operative-side arm wrapped and elevated to expose the axillary fossa endoscopically. After SLN excision and frozen-section analysis, the lateral edge of the pectoralis major was exposed. A sterile glove finger was used to sheath a wound retractor.Using the electrosurgical hook, the retromammary fat was dissected from the pectoralis major to a defined boundary, carefully preserving the serratus anterior fascia laterally and inferolaterally. Dissection then continued along the marked lateral margin. Subcutaneous breast dissection proceeded with Peng's dissector until the nipple base was transected and sent for frozen section.Fat was harvested via tumescent liposuction from the abdomen or thighs, manually centrifuged, and loaded into 10-mL syringes. It was then injected through the axillary incision into the intramuscular, intermuscular, and submuscular planes of the serratus anterior and pectoralis major muscles.
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
• Age \>18 years, female * Stage 0-II( pTis,cT1-2N0-1M0） * Candidate for a endoscopic nipple- sparing mastectomy procedure (multiple or extensive lesions) * Patients' choice to undergo an immediate breast reconstruction * Lack of serious comorbidities * Accept standard adjuvant therapy
Exclusion criteria
* Breast cancer in pregnancy, tumours abutting the chest wall, skin (including inflammatory breast cancer), or nipple-areolar complex (NAC) (including Paget's disease), patients with breast cancer diagnosed as T3 or N2 and above, Allergic to lidocaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life(QoL) | 12 months | QoL at 12 months after the final surgery. The BREAST-Q , version 2.0,22 which was used for measuring pre- and post reconstrucution, has several domains, 3 of which are evaluated for QOL. |
| The BREAST-Q score | 12months | Quality of life at 12 months after the final surgery. The BREAST-Q , version 2.0,22 which was used for measuring pre- and post reconstrucution, has several domains, 3 of which are evaluated for QOL: psychosocial well-being, sexual well-being, physical well-being: chest |
Countries
China
Outcome results
None listed