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Clinical Trials/KCT0007592
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional Study
Sex
All

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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