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 range
18 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.