Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
Recruiting · NCT06823414 · Observational (researchers observe without assigning treatment) · Lead sponsor: Alejandra García-Novoa
View the official record on ClinicalTrials.gov →Interventions studied
Video assisted mastectomy
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4 - A Coruña, Galicia, Spain