ESM Versus OM :A Randomized Controlled Trial

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Capital Medical University

Status

Unknown

Conditions

Endoscopic Subcutaneous Mastectomy

Treatments

Procedure: endoscopic subcutaneous mastectomy
Procedure: subcutaneous mastectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04461847
BFH-BC

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

287 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy 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

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

287 participants in 2 patient groups

patients underwent ESM
Experimental group
Treatment:
Procedure: endoscopic subcutaneous mastectomy
patients underwent SM
Active Comparator group
Treatment:
Procedure: subcutaneous mastectomy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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