None listed
Conditions
Interventions
Procedure/Surgery : RNSM and CNSM procedures are systematic at 1:1 ratio after obtaining consent forms for research participation and checking criteria for exclusion from selection
It is randomly assi
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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) an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactDa Young Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed