Endoscopic Skin-Sparing vs. Conventional Mastectomy for Wound Complications in BC

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University258 enrolled

Overview

This randomized, open-label study compares endoscopic skin-sparing mastectomy (E-SSM) with conventional mastectomy (CM) in female patients with unilateral invasive breast cancer (T1-4aN0-3M0). The primary objective is to evaluate differences in postoperative wound complications and patient satisfaction, with secondary outcomes including breast appearance and oncological safety. Eligible patients have a breast volume ≤ cup C and no/mild ptosis (grade I-II). A total of 258 participants (129 per group) will be enrolled across multiple centers and randomized by site. This study aims to provide evidence for selecting optimal endoscopic surgical strategies, address the evidence gap for E-SSM without immediate reconstruction, and advance the precision of breast cancer surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

258

Conditions

Breast Cancer

Interventions

Endoscopic skin-sparing mastectomy (E-SSM). Under endoscopic assistance, the breast skin and partial subcutaneous tissue are preserved, while the breast parenchyma, and nipple-areola complex are resected according to oncological principles. This approach aims to maintain breast envelope integrity while ensuring oncological safety.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients aged 18 to 75 years * Pathologically confirmed invasive breast cancer * Clinical stage cT1-4a N0-3 M0 * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Unilateral breast cancer * Left ventricular ejection fraction (LVEF) ≥ 50% * Hematological and renal function with the following parameters: White blood cell count ≥ 3.0 × 10⁹/L; Neutrophil count ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Serum creatinine ≤ 1.5 × upper limit of normal (ULN) * No planned breast reconstruction Exclusion Criteria: * Tumor invasion of the skin * Diffuse malignant microcalcifications * Breast cancer during pregnancy or lactation * History of another primary malignancy * Severe cardiopulmonary, hepatic or renal dysfunction, or other significant systemic diseases

Outcomes

Primary Outcomes

Wound Complication Rate

Wound complications are defined as wound dehiscence requiring surgical debridement, dressing change, or packing, or persistent wound discharge, occurring prior to completion of adjuvant chemotherapy and radiotherapy. The rate is calculated as: (Number of patients with ≥1 wound complication / Total surgical patients in the group) × 100%

Time frame: occurring prior to completion of adjuvant chemotherapy and radiotherapy, about 6-12 months postoperatively

Secondary Outcomes

Patient Satisfaction

Breast satisfaction score from the Breast Q questionnaire at 6 months postoperatively. Patients will complete the self-reported Breast Q survey under physician guidance, which takes 1-4 minutes for the breast satisfaction module and 10-15 minutes for the full survey.

Time frame: 6 months postoperatively

Postoperative Breast Appearance

Overall aesthetic score using the Ueda scale (0-10, 0=poor, 10=excellent) assessed by physicians, and scar appearance score using the Scar-Q scale (0-100, 4 domains) self-reported by patients, both evaluated at 6 months postoperatively.

Time frame: 6 months postoperatively

Surgical Time

Time from initial incision to completion of wound closure, measured in minutes.

Time frame: intraoperative

Intraoperative Blood Loss

Total volume of blood lost during surgery, measured in milliliters (mL).

Time frame: intraoperative

Rate of Other Postoperative Adverse Complications

Percentage of patients experiencing other postoperative complications (e.g., edema, bleeding) during the follow-up period, calculated as: (Number of patients with ≥1 other complication / Total patients in the group) × 100%

Time frame: up to 24 months

Overall Survival (OS)

Time from the date of surgery to death from any cause. Patients who remain alive will be censored at the last follow-up date.

Time frame: From date of surgery until the date of death from any cause, assessed up to 60 months

Disease-Free Survival (DFS)

Defined as the time from the date of surgery to the first occurrence of any of the following events: local recurrence, regional recurrence, distant metastasis, or death from any cause. Patients without any event were censored at the last follow-up date.

Time frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.