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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video assisted mastectomy | Patients with a video-assisted nipple skin sparing mastectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video assisted mastectomy | Other | Nipple Skin sparing mastectomy assisted by endoscopic or robotic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Loss | Safety of the reconstruction technique, calculated by the number of implants lost | First year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| local relapse | evaluate oncological safety in terms of local relapses | first 5 years |
| Glandular residual tissue | Residual glandular tissue after endoscopic mastectomy identified by magnetic resonance imaging one year after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with breast cancer or high risk for breast cancer who need a mastectomy. The mastectomy will be skin and nipple preserving and will be performed with endoscopic assistance
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alejandra García Novoa, PhD MD | Contact | 981178000 | 296113 | maria.alejandra.garcia.novoa@sergas.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4 | Recruiting | A Coruña | Galicia | 15006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. Acea-Nebril B, García-Novoa A, Cereijo-Garea C, Conde C, Bouzón A, Díaz C. Safety and Quality of Life in Women with Immediate Reconstruction with Polyurethane Implants after Neoadjuvant Chemotherapy: Outcomes from The Preq-20 Trial. Cancers 2023;15(4):1113. doi: 10.3390/cancers15041113. 2. Acea B, García A, García L, Díaz C, Bouzón A, Conde C. Immediate breast reconstruction by prepectoral polyurethane implant: Preliminary results of the prospective study PreQ-20. Cir Esp (Engl Ed) 2023;101(3):187-197. doi: 10.1016/j.cireng.2022.09.021. 3. Nakajima H, Sakaguchi K, Mizuta N, et al. Video-assisted total glandectomy and immediate reconstruction for breast cancer. Biomed Pharmacother 2002;56 Suppl 1:205s-8s. 4. Wei Ch, Lai HW. Endoscopic-assisted surgery in the management of breast cancer: 20 years review of trend, techniques and outcomes. Breast; 2019:46:144-156. doi: 10.1016/j.breast.2019.05.013. 5. Wei Ch, Lai HW. Evolution of minimal access breast surgery. Gland Surg 2019;8(6):784-793. doi: 10.21037/gs.2019.11.16. 6. Toesca A, Paradze N, Manconi A, Galimberti V, Intra M, Colleoni M et al. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast 2017; Feb:31:51-56. doi: 10.1016/j.breast.2016.10.009. 7. Rathat G, Herlin C, Bonnel C, Captier G, Duraes M. Endoscopic Nipple-Sparing Mastectomy with Immediate Prepectoral Implant-Based Reconstruction: A Case Report Am J Case Rep 2019;20:1812-1816. doi: 10.12659/AJCR.919669. |
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| first year |
| Suvival | Overall survival | 5 years |