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The consideration of quality of life issues has led to the development of alternative surgeries for breast cancer patients, particularly in the case of localized disease. Nipple-sparing subcutaneous mastectomy (SM), for example, was designed to preserve the nipple-areola complex which facilitates breast reconstruction. However, SM still leaves behind a conspicuous scar.There have already been some observation study show that endoscopic subcutaneous mastectomy(ESM) can improve the cosmesis outcomes and at the same time as safe as the traditional SM.However there is no RCT in this field.That is why the investigators design this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients underwent ESM | Experimental |
| |
| patients underwent SM | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subcutaneous mastectomy | Procedure | Operating subcutaneous mastectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| local recurrence rate | Definition and diagnostic criteria of local recurrence: physical examination or imaging examination found lesions in the same side of breast, chest wall or skin and surgical scars, and confirmed by histology as breast cancer of the same tissue type; 12 months after operation, the evaluation was carried out. | 12 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Distant metastasis | Definition and diagnosis criteria of distant metastasis: the lesions appeared in the distant organs other than breast and surrounding tissues, such as bone, lung, liver, brain, etc., and were diagnosed as breast cancer metastasis by imaging or histology; the evaluation was carried out 12 months after operation. | 12 months after operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35501091 | Derived | Wang ZH, Ding G, Wu S, Song JN, Ge ZC, Zhang H, Yuan Z, Gao YG, Gang TR, Zhang Z, Qu X. Oncological outcome of single-port insufflation endoscopic nipple-sparing mastectomy versus open mastectomy in early breast cancer patients: a study protocol for a randomised controlled trial. BMJ Open. 2022 May 2;12(5):e047866. doi: 10.1136/bmjopen-2020-047866. |
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| ID | Term |
|---|---|
| D015414 | Mastectomy, Subcutaneous |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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| endoscopic subcutaneous mastectomy |
| Procedure |
Operating endoscopic subcutaneous mastectomy |
|