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

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.

Conditions

• Breast Cancer Early Stage Breast Cancer (Stage 1-3)

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.

Sponsors & Collaborators

• West China Tianfu Hospital, Sichuan University

  collaborator UNKNOWN

• West China School of Public Health and West China Fourth Hospital, Sichuan University

  collaborator UNKNOWN

• The Fourth People's Hospital of Sichuan Province

  collaborator UNKNOWN

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Shanxi Bethune Hospital

  collaborator OTHER

• Chengdu Fifth People's Hospital

  collaborator OTHER

• Suzhou Municipal Hospital

  collaborator OTHER

• Taiyuan Central Hospital of Shanxi Medical University

  collaborator OTHER

• The People's Hospital of DAZU ，Chongqing

  collaborator UNKNOWN

• Anyang City Tumor Hospital

  collaborator UNKNOWN

• Mianyang Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Deyang People's Hospital

  collaborator OTHER

• Hunan University of Traditional Chinese Medicine

  collaborator OTHER

• The Affiliated Hospital of lnner Mongolia Medical University

  collaborator UNKNOWN

• Guangzhou First People's Hospital

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• Nanchang People's Hospital

  collaborator UNKNOWN

• Du Zhenggui

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-17

Primary Completion

2026-06-01

Completion

2031-12-31

Countries

• China

Study Locations