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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
4
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Feasibility of removal of breast gland en bloc through RNSM
Measure number of patients who had breast removed en bloc through RNSM incision.
Time frame: Up to 1 year
Complication rate of patients with bleeding requiring re-operation
Number of patients with bleeding requiring re-operation after RNSM.
Time frame: Up to 1 year
Complication rate of patients with infection requiring antibiotics or re-operation
Number of patients with infection after surgery requiring antibiotics or re-operation.
Time frame: Up to 1 year
Complication rate of patients with Mastectomy flap (SKIN flap score)
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.
Time frame: Up to 1 year
Perioperative Outcomes investigating the total duration of surgical time
Investigate the total duration of the operation (surgical time data),
Time frame: Up to 1 year
Perioperative Outcomes investigating length of surgery time
Investigate the total duration of the operation (surgical time data) of each patient
Time frame: Up to 1 year
Perioperative Outcomes investigating the length of hospitalization
Investigate the length of hospitalization for each patient
Time frame: Up to 1 year
Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey
Surgery Task Load Index (SURG-TLX) survey from each surgeon performing surgery.
Time frame: Up to 1 year
Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire
Musculo-Skeletal Questionnaire (NMSQ) from each surgeon performing surgery.
Time frame: Up to 1 year
Patient Reported Outcomes
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.
Time frame: Up to 1 year
Patient Reported Outcomes
Patient satisfaction with the breast after surgery measured by BREAST-Q survey. Lowest score = 0, highest = 100 with higher scores indicating better outcomes / quality of life.
Time frame: Up to 1 year
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