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The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
Sponsor: Du Zhenggui
Summary
This study is a multicenter, open-label, randomized controlled trial. It will prospectively compare outcomes between patients undergoing reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) with the "HUAXI Hole 1" versus without the "HUAXI Hole 1". The study aims to evaluate differences in operative efficiency, surgical safety, postoperative aesthetics, and oncological safety between the two groups.
Official title: The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction: A National Multicenter, Open-Label, Randomized Controlled Trial (HUAXI-h-01)
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
337
Start Date
2025-06-17
Completion Date
2031-12-31
Last Updated
2025-07-02
Healthy Volunteers
No
Interventions
HUAXI hole 1
A small incision of 2mm is made at the junction of the upper outer edge of the areola and the skin, through which the scalpel is placed to assist in the resection of breast glands in reverse-sequence nipple-sparing mastectomy and direct-to-implant breast reconstruction.
Locations (20)
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Anyang City Tumor Hospital
Anyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
The Affiliated Hospital of lnner Mongolia Medical University
Hohhot, Inner Mongolia, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Nanchang People's Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Taiyuan Central Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The Fourth People's Hospital of Sichuan Province
Chengdu, Sichuan, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China hospital of Sichuan University
Chengdu, Sichuan, China
West China School of Public Health and West China Fourth Hospital, Sichuan University
Chengdu, Sichuan, China
West China Tianfu Hospital
Chengdu, Sichuan, China
Deyang People's Hospital
Deyang, Sichuan, China
Mianyang Hospital of Traditional Chinese Medicine
Mianyang, Sichuan, China
The People's Hospital of Dazu, Chongqing
Chongqing, China