Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy

Alejandra García-Novoa

Status: Enrolling

Conditions: Breast Cancer Non-invasive Breast Cancer; High Risk Breast Carcinoma; Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Treatments: Other: Video assisted mastectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06823414

VideoBreast-24

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

126 participants in 1 patient group

Video assisted mastectomy

Description:

Patients with a video-assisted nipple skin sparing mastectomy

Treatment:

Other: Video assisted mastectomy