A Prospective Multicenter Randomized Clinical Trial: Robot-assisted vs. Open nipple-sparing Mastectomy with Immediate Breast Reconstruction (ROM) trial
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 790
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
- 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) an
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival
- Secondary Outcome Measures
Name Time Method overall survival, OS;breast cancer-specific survival, BCSS;distant recurrence-free survival, DRFS;locoregional recurrence-free survival, LRFS;nipple recurrence, NR;Margin positive rates;Open conversion rate (RNSM arm only);Operation time;Postoperative complication rates in postoperative 30 days;Estimation of postoperative complications rates in 30 days ;Clavien-Dindo grade of postoperative complications in postoperative 180 days;Implant or graft (flap) loss rates within 1 year from surgery;Patient reported outcomes in postoperative 3 – 12 months from the definitive surgery (patient satisfaction);Surgeon's satisfaction in postoperative 3 – 12 month;Cost-effectiveness in postoperative 3 month to 1 year