Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique (NCT03440398) | Clinical Trial Compass
CompletedNot Applicable
Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique
Italy82 participantsStarted 2017-03-31
Plain-language summary
This trial is designed to compare robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with conventional open technique. It is a prospective randomized trial evaluating patients satisfaction
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Invasive breast cancer, Ductal Carcinoma In Situ, Breast Related Cancer Antigens mutation carriers.
* Any age
* Candidates to nipple-sparing mastectomy and immediate breast reconstruction
* Negative preoperative assessment of nipple-areola complex
* Absence of skin involvement
* Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section
* Breast volume ≤ Bra IV; from cup A to D
* No hard smoking (hard smoking defined as \>20 cigarettes/day)
* Low and intermediate risk for anesthesia (ASA Scale)
* Written informed consent must be signed and dated by the patient and the investigator prior to inclusion
* Patients must be accessible for follow-up
Exclusion criteria:
* Previous thoracic radiation therapy for any reason
* Inflammatory Breast Cancer
* Skin involvement
* Pre-operative diagnosis (radiological or cytological) of nipple-areola complex disease
* Pregnancy
* Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
* Uncompensated Diabetes Mellitus
* Hard smokers (hard smoking defined as \>20 cigarettes/day)
* High risk for anesthesia