Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ohio State University Comprehensive Cancer Center
With the advances of breast reconstruction after mastectomy for the treatment of breast diseases including breast cancer, surgical techniques have evolved to preserve the skin flaps and nipple areolar complex (NAC) to give better aesthetic outcome without compromising outcome. Mastectomy that preserves the NAC is called nipple sparing mastectomy (NSM). NSM can provide major psychosocial benefits for patients but is technically demanding and challenging to perform. Total mammary glandular excision in NSM can be technically challenging due to small size of the incision and poor visualization of dissection plane. Recent studies demonstrate feasibility and safety of performing minimally invasive robot-assisted NSM (RNSM). The technique of RNSM is still novel.
This is a single-arm pilot study for feasibility and safety of RNSM.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Surgical candidates, per standard of care for:
* Nipple sparing resection and reconstruction OR
* Prophylactic mastectomy for risk reduction mastectomy OR
* Treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer
Surgical candidates for open NSM, per standard of care, with regards to patient anatomic factors and tumor location
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You may not be if
Pregnant or nursing women
Patients with:
* Inflammatory breast cancer
* Skin involvement with tumor
* Pre-operative diagnosis (radiological or pathologic) of nipple-areola complex involvement with tumor
* Grade 3 ptosis of nipple
Smokers with heavy current use of nicotine (defined as \> 20 cigarettes/day)
Patients that are high risk for anesthesia, as documented in medical record
Patients that do not have the ability to give informed consent
Prisoner status at surgical clinic visit
Bra cup size greater than C cup
Previous thoracic radiation history (for any reason)
Clareo Health | Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)
