Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Ductal Breast Carcinoma In Situ, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prophylactic Mastectomy
Conditions
Brief summary
This is a pilot study to determine safety, efficacy, and potential risks of robot assisted nipple sparing mastectomy (RNSM), by utilizing the daVinci surgical system.
Detailed description
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.
Interventions
PROCEDURERobot-assisted Nipple Sparing Mastectomy
Under RNSM
OTHERSurvey Administration
ancillary correlative
DEVICERNSM
Robot-assisted Nipple Sparing Mastectomy
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Outcomes investigating the length of hospitalization | Up to 1 year | Investigate the length of hospitalization for each patient |
| Complication rate of patients with Mastectomy flap (SKIN flap score) | Up to 1 year | Number of patients with mastectomy flap or nipple-areolar complex necrosis as measured using the SKIN flap score after surgery. Score of A1 indicates normal skin, D4 indicates total full thickness necrosis. |
| Perioperative Outcomes investigating the total duration of surgical time | Up to 1 year | Investigate the total duration of the operation (surgical time data), |
| Perioperative Outcomes investigating length of surgery time | Up to 1 year | Investigate the total duration of the operation (surgical time data) of each patient |
| Feasibility of removal of breast gland en bloc through RNSM | Up to 1 year | Measure number of patients who had breast removed en bloc through RNSM incision. |
| Complication rate of patients with bleeding requiring re-operation | Up to 1 year | Number of patients with bleeding requiring re-operation after RNSM. |
| Complication rate of patients with infection requiring antibiotics or re-operation | Up to 1 year | Number of patients with infection after surgery requiring antibiotics or re-operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire | Up to 1 year | Musculo-Skeletal Questionnaire (NMSQ) from each surgeon performing surgery. |
| Patient Reported Outcomes | Up to 1 year | Monofilament testing to test for sensation recovery after surgery from each participant. Semmes Weinstein monofilament exam; sensation to series of monofilament with different thickness, compare sensation to preoperative exam. |
| Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey | Up to 1 year | Surgery Task Load Index (SURG-TLX) survey from each surgeon performing surgery. |
Countries
United States
Outcome results
None listed