ESM Versus OM ：A Randomized Controlled Trial
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Details and patient eligibility
About
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.
Enrollment
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Ages
Volunteers
Inclusion criteria
- Diagnosis of stages I or II ductal carcinoma
- 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
- Age from 18~70
- ECOG scores 0~2
- Normal function of liver, kidney and bone marrow
Exclusion criteria
- 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.
- There are serious medical diseases
- Pregnant or lactating women women of childbearing age -
Trial design
Primary purpose
Allocation
Interventional model
Masking
287 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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