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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoscopic-assisted mastectomy and immediate breast reconstruction | Experimental | endoscopic-assisted mastectomy and immediate breast reconstruction |
|
| mastectomy and immediate breast reconstruction | Experimental | mastectomy and immediate breast reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic-assisted mastectomy and immediate breast reconstruction | Procedure | endoscopic-assisted mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Local 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. | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Distant metastasis free survival rate (DMFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Ding, Professor | Contact | 13951731373 | dingqiang@njmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| mastectomy and immediate breast reconstruction | Procedure | conventional mastectomy and sentinel lymph node biopsy/axillary lymph node dissection in the management of breast cancer |
|
Distant transfer refers to the transfer to any other location.
| 3 years |
| Main complication rate | The Clavien-Dindo classification of surgical complications, including long term outcomes and short term outcomes. | 3 years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008408 | Mastectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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