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RECRUITING
NCT06995118
NA

The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction

Sponsor: Du Zhenggui

View on ClinicalTrials.gov

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

PROCEDURE

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