Robotic-assisted nipple-sparing mastectomy for breast cancer
Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy and Inmediate Reconstruction With Prepectoral Implant. Prospective Study for the Evaluation of the Feasibility and Safety of the Technique, Quality of Life and Cosmetic Results
This study is testing if robotic-assisted nipple-sparing mastectomy is a safe and effective option for women with early-stage breast cancer or those at high risk, compared to traditional surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital A Coruña Academic / other |
| Locations | 1 site (A Coruña, Galicia) |
| Trial ID | NCT06823414 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women requiring a mastectomy for early-stage breast cancer or those at high risk for breast cancer without the need for skin reduction.
Not a fit: Patients with sarcomas, benign breast tumors, or those requiring significant skin resection will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved cosmetic outcomes and reduced recovery times for patients undergoing mastectomy.
How similar studies have performed: Previous studies have shown promising results with video-assisted mastectomy techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
A Coruña, Galicia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.