Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction (ROM)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer
Eligibility Criteria
Inclusion Criteria:
- Adult women over the age of 19 with breast cancer scheduled for therapeutic mastectomy and who want immediate reconstruction
- Stage 0-III breast cancer at initial evaluations
- ECOG performance status of 0 or 1
Exclusion Criteria:
- Patients planned for breast-conserving surgery or who are not candidates for IBR are excluded.
- Clinical evidence for nipple or skin involvement of tumors in preoperative evaluations
- A pregnant or lactating woman
- Only tumors with lobular carcinoma in situ
- Mammary Paget's disease
- Inflammatory breast cancer
- Male breast cancer
- Stage IIIB-IV disease at initial presentation
- Women with breast Cup E or higher
- Previous history of breast cancer (metachronous breast cancer)
- Previous history of non-mammary malignant disease excluding non-melanoma skin cancer or thyroid papillary/follicular cancer
- Special type cancer (phyllodes tumor, sarcoma, and lymphoma)
- Age > 70
- ASA, grade 4 or higher
- Patients who do not have the ability to give informed consent
- Previous thoracic radiation history
- Patients who have not been tested for hepatitis before surgery (HBV, HCV) and HIV (compensation insurance policy)
Sites / Locations
- Yonsei University Health System, Severance Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
robot assisted nipple sparing mastectomy(RNSM)
Conventional nipple sparing mastectomy(CNSM)
Robotic papillary preservation mastectomy, robotic mastectomy, robotic papillary preservation mastectomy, hybrid robotic papillary preservation mastectomy, robotic papillary mammary complex, and skin preservation mastectomy robot papillary preservation mastectomy
Total mastectomy, mastectomy, papillary preservation mastectomy, skin preservation mastectomy, papillary preservation breast resection, open papillary preservation, open nipple sparing mastectomy) mastectomy, general papillary preservation Mammastectomy, an open-window papillary preservation