NCT04461847

ESM Versus OM ：A Randomized Controlled Trial

A Randomized Controlled Trial of Endoscopic Subcutaneous Mastectomy Versus Open Mastectomy in Early Breast Cancer Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 287 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
PROCEDURE	subcutaneous mastectomy	Operating subcutaneous mastectomy
PROCEDURE	endoscopic subcutaneous mastectomy	Operating endoscopic subcutaneous mastectomy

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-07-08
• Last updated: 2020-12-01

Locations

1 site across 1 country: China