The new technology of endoscopic-assisted system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of endoscopic-assisted mastectomy and immediate breast reconstruction in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, double-arm clinical study was conducted to use the endoscopic-assisted system and evaluate the effectiveness and safety of the mastectomy combined with immediate breast reconstruction in breast cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
800
endoscopic-assisted mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer
conventional mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGLocal recurrence free survival rate (LRFS)
Local recurrence refers to the recurrence of the chest wall or breast on the same side as the surgical site.
Time frame: 3 years
Regional recurrence free survival rate (RRFS)
Regional recurrence refers to the recurrence in the drainage area of ipsilateral internal mammary lymph nodes, axillary lymph nodes, or supraclavicular and infraclavicular lymph nodes.
Time frame: 3 years
Disease free survival (DFS)
The time from entry into the study to the first tumor recurrence or metastasis, or death of the subject for any reason.
Time frame: 3 years
Distant metastasis free survival rate (DMFS)
Distant transfer refers to the transfer to any other location.
Time frame: 3 years
Main complication rate
The Clavien-Dindo classification of surgical complications, including long term outcomes and short term outcomes.
Time frame: 3 years
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