Early breast cancer (clinical-stage cTis,1-2 N0)
Conditions
Interventions
None listed
Sponsors
Takayama Shin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Be histologically diagnosed as breast cancer 2)Female 3)Age 18 or older (at the time of informed consent) 4)People who have given informed consent to perform R-NSM 5)Written informed consent to participate in the study has been obtained from the individual
Exclusion criteria
Exclusion criteria: 1)Tumour-to-skin distance less than 5mm 2)Tumour and nipple areola complex less than 1cm 3)Based on Regnault class, breast ptosis grade is 3 or higher. 4)BMI 30 or higher (at the time of informed consent) 5)For risk-reducing mastectomy (RRM) for hereditary breast and ovarian cancer (HBOC) 6)Other than the above, when the physician judges it to be inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative morbidity of R-NSM related Clavien-Dindo class 3 or higher occurring in the first 30 postoperative days | — |
Secondary
| Measure | Time frame |
|---|---|
| -Rate of conversion to conventional or other operative procedures under direct vision -Surgical outcomes (R-NSM completion rate, operation time, consolidation time, specimen size and weights, incisional position and length, NAC preservation rate, blood loss, blood transfusion or not) -Postoperative recovery (length of hospital stay and days of drain placement) -Postoperative complications (type and incidence of complications occurring 5 years after surgery or before discontinuation/transfer) -Proportion of reoperations, readmissions, and unplanned revisits (incidence up to 5 years after surgery) -Oncologic evaluation and outcome (positive margin rate, local recurrence rate, and survival rate). -Harvard scale, BCCT.core -QOL(EQ-5D, BREAST-Q) -Operator QOL(NASA-TLX). | — |
Contacts
Public ContactChikashi Watase
National Cancer Center Hospital
Outcome results
None listed