Endoscopic Nipple-Sparing Mastectomy (E-NSM) With Immediate Multistage Autologous Fat Grafting(IMAFG) for Total Breast Reconstruction Via the Axillary Incision

Condition(s) studied

Investigational drug(s) / intervention(s)

endoscopic 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

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