Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer, High Risk Breast Carcinoma
Conditions
Brief summary
Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.
Interventions
OTHERVideo assisted mastectomy
Nipple Skin sparing mastectomy assisted by endoscopic or robotic
Sponsors
Alejandra García-Novoa
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women who require a mastectomy and who do not require skin reduction or resection are included. Women with both breast cancer and those at high risk for breast cancer are included.
Exclusion criteria
* Sarcomas of the breast. * Benign breast tumors. * Prepectoral reconstruction with expansion. * Impossibility to preserve the skin. * Need for reduction pattern * Inability to perform an MRI during follow-up (obesity, claustrophobia, etc.). * Inability to complete the BREAST-Q™ questionnaire due to the patient's cognitive alterations. * Refusal of the patient to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Loss | First year after surgery | Safety of the reconstruction technique, calculated by the number of implants lost |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local relapse | first 5 years | evaluate oncological safety in terms of local relapses |
| Glandular residual tissue | first year | Residual glandular tissue after endoscopic mastectomy identified by magnetic resonance imaging one year after the intervention |
| Suvival | 5 years | Overall survival |
Countries
Spain
Contacts
Primary ContactAlejandra García Novoa, PhD MD
Outcome results
None listed