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RecruitingNCT06823414

Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy

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

Sponsor

Alejandra García-Novoa

Enrollment

126 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)Breast Cancer Non-invasive Breast CancerHigh Risk Breast Carcinoma

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria1

  • 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 Criteria8

  • 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.

Interventions

OTHERVideo assisted mastectomy

Nipple Skin sparing mastectomy assisted by endoscopic or robotic

Locations(1)

Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4

A Coruña, Galicia, Spain

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NCT06823414

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