Status:
UNKNOWN
Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique
Lead Sponsor:
European Institute of Oncology
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 patien...
Detailed Description
High proportion of patients with newly diagnosed early-stage breast cancer in Europe and US undergo to mastectomy. The absolute numbers of mastectomy rates in US is still today around 38% and represen...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2023
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT03440398
Start Date
March 31 2017
End Date
December 10 2023
Last Update
June 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
European Institute of Oncology
Milan, Italy, 20145