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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-SSM | Experimental | endoscopic skin-sparing mastectomy |
|
| CM | Active Comparator | conventional mastectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic skin-sparing mastectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | occurring prior to completion of adjuvant chemotherapy and radiotherapy, about 6-12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shicheng Su | Contact | +86 13631304227 | sushch@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shicheng Su | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Conventional mastectomy | Procedure | Conventional mastectomy (CM). The breast tissue, nipple-areola complex, and a full thickness of skin and subcutaneous tissue within the traditional resection range are removed. This is the standard surgical approach for breast cancer. |
|
| 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. |
| 6 months postoperatively |
| Surgical Time | Time from initial incision to completion of wound closure, measured in minutes. | intraoperative |
| Intraoperative Blood Loss | Total volume of blood lost during surgery, measured in milliliters (mL). | 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% | 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. | 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. | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |