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.
Female patients aged 18-70 years (inclusive18 and 70 years);
Patients eligible for unilateral or bilateral reverse-sequence endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction, with concurrent contralateral endoscopic augmentation mammoplasty permitted;
Patients with preoperative pathological confirmation of non-specialized breast cancer (e.g., ductal carcinoma in situ, invasive ductal carcinoma, invasive lobular carcinoma) or eligibility for prophylactic mastectomy;
For non-specialized breast cancer patients, preoperative tumor size ≤5 cm (post-neoadjuvant chemotherapy if applicable), and no clinical or imaging evidence of invasion to the nipple, skin, subcutaneous fat, chest wall (referring to the bony thorax and intercostal muscles, excluding the pectoralis major and minor muscles) or distant metastasis preoperatively;
History of open breast surgery within 1 year before this procedure (excluding minimally invasive vacuum-assisted biopsy);
Breast cancer diagnosed during pregnancy or lactation;
Subnipple-plane scarring with radiotherapy;
Metastatic breast cancer (M1);
Parallel
HUAXI hole 1
Procedure/SurgeryA 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.
Operative time
Overall operation time (minute) from skin incision to complete closure of incision, including breast cancer operations, lymph node surgery, and breast reconstructions.
Complications
Skin flap thermal injury, skin flap ischemia/necrosis, nipple and areola complex(NAC) ischemia/necrosis, surgical site infection, incision dehiscence, surgical site bleeding or hematoma, seroma needing repeated aspiration or drain reinsertion, capsular contracture, prosthesis outline appearance, rippling, implant displacement, implant loss, readmission
Aesthetic outcome evaluation--BREAST-Q scores
The Satisfaction with Breasts module of BREAST-Q questionnaire is utilized to assess patient-reported aesthetic outcomes. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores
Aesthetic outcome evaluation--Harris score
The Harris score was used to record the subjective judgment of symmetry of the reconstructed breast compared to the contralateral breast. The results were categorized as excellent (treated breast nearly identical to untreated breast), good (treated breast slightly different than untreated), fair (treated breast clearly different than untreated), and poor (treated breast seriously distorted).
Aesthetic outcome evaluation--Ueda score
Doctor-reported aesthetic outcomes will be evaluated by three professional breast surgeons using the Ueda scale, based on postoperative photographs. Scores range from 0 to 10 points, with higher values indicating better results. The categorized as follows: Excellent (≥9 points), Good (7-8 points), Fair (5-6 points), Poor (≤4 points). Both raw scores and categorizations will be documented
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Du Zhenggui
Lead sponsor
West China Hospital
Sponsor institution
West China Tianfu Hospital
Collaborator
West China Fourth Hospital
Collaborator
Fourth People's Hospital of Sichuan Province
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
The First Hospital of Jilin University
Collaborator
Shanxi Bethune Hospital
Collaborator
Chengdu Fifth People's Hospital
Collaborator
Suzhou Municipal Hospital
Collaborator
Taiyuan Central Hospital of Shanxi Medical University
Collaborator
The People's Hospital of DAZU ，Chongqing
Collaborator
Anyang City Tumor Hospital
Collaborator
Mianyang Hospital of Traditional Chinese Medicine
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Deyang People's Hospital
Collaborator
Hunan University of Traditional Chinese Medicine
Collaborator
The Affiliated Hospital of Inner Mongolia Medical University
Collaborator
Guangzhou First People's Hospital
Collaborator
Fujian Medical University Union Hospital
Collaborator
Nanchang People's Hospital
Collaborator
