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ESM Versus OM ：A Randomized Controlled Trial

NCT04461847 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2020-12-01

No results posted yet for this study

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.

Conditions

  • Endoscopic Subcutaneous Mastectomy

Interventions

PROCEDURE

subcutaneous mastectomy

Operating subcutaneous mastectomy

PROCEDURE

endoscopic subcutaneous mastectomy

Operating endoscopic subcutaneous mastectomy

Sponsors & Collaborators

  • Beijing Friendship Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04461847 on ClinicalTrials.gov