Robotic-assisted nipple-sparing mastectomy for breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the feasibility and outcomes of video-assisted nipple-sparing mastectomy techniques, including endoscopic and robotic approaches, compared to traditional open mastectomy. It focuses on assessing oncological safety, cosmetic results, and overall patient satisfaction. Women with early-stage breast cancer or those at high risk for breast cancer who require a mastectomy without skin reduction are eligible for participation. The study aims to gather data on the effectiveness and safety of these innovative surgical techniques.

Why it matters

Who can join: the full rules

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's running

• Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4
  A Coruña, Galicia, Spain Recruiting

Study contacts

• Study coordinator: Alejandra García Novoa, PhD MD
• Email: maria.alejandra.garcia.novoa@sergas.es
• Phone: 981178000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.