KCT0007592
Not yet recruiting
未知
A Prospective Multicenter Randomized Clinical Trial: Robot-assisted vs. Open nipple-sparing Mastectomy with Immediate Breast Reconstruction (ROM) trial
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 790
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult women over the age of 19 with breast cancer scheduled for therapeutic mastectomy and who want immediate reconstruction
- •2\. Stage 0\-III breast cancer at initial evaluations
- •3\. 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)
Outcomes
Primary Outcomes
Not specified
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