Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
NCT ID: NCT06823414
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
126 participants
OBSERVATIONAL
2025-02-01
2034-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Video assisted mastectomy
Patients with a video-assisted nipple skin sparing mastectomy
Video assisted mastectomy
Nipple Skin sparing mastectomy assisted by endoscopic or robotic
Interventions
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Video assisted mastectomy
Nipple Skin sparing mastectomy assisted by endoscopic or robotic
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Alejandra García-Novoa
OTHER
Responsible Party
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Alejandra García-Novoa
Principal Investigator
Locations
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Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4
A Coruña, Galicia, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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VideoBreast-24
Identifier Type: -
Identifier Source: org_study_id
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