Endoscopic Subcutaneous Mastectomy
Conditions
Brief summary
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.
Interventions
PROCEDUREsubcutaneous mastectomy
Operating subcutaneous mastectomy
PROCEDUREendoscopic subcutaneous mastectomy
Operating endoscopic subcutaneous mastectomy
Sponsors
Beijing Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Diagnosis of stages I or II ductal carcinoma 2. The distance from the tumor to the edge of the papilla is more than 3cm, the tumor volume is less than 3cm, the axillary lymph nodes have no obvious fusion and no adhesion with the axillary vein and brachial plexus 3. Age from 18\ 70 4. ECOG scores 0\ 2 5. Normal function of liver, kidney and bone marrow
Exclusion criteria
1. Through physical examination and MRI, it was confirmed that the tumor did not invade the skin, but was confined to the gland and did not invade the surface of the gland. 2. There are serious medical diseases 3. Pregnant or lactating women women of childbearing age -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| local recurrence rate | 12 months after operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant metastasis | 12 months after operation | 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. |
Countries
China
Outcome results
None listed