Anatomic Stage II Breast Cancer AJCC v8 Clinical Trial
Official title:
Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM)
Verified date | March 2024 |
Source | Ohio State University Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 4 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
William Carson |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of removal of breast gland en bloc through RNSM | Measure number of patients who had breast removed en bloc through RNSM incision. | Up to 1 year | |
Primary | Complication rate of patients with bleeding requiring re-operation | Number of patients with bleeding requiring re-operation after RNSM. | Up to 1 year | |
Primary | Complication rate of patients with infection requiring antibiotics or re-operation | Number of patients with infection after surgery requiring antibiotics or re-operation. | Up to 1 year | |
Primary | 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. | Up to 1 year | |
Primary | Perioperative Outcomes investigating the total duration of surgical time | Investigate the total duration of the operation (surgical time data), | Up to 1 year | |
Primary | Perioperative Outcomes investigating length of surgery time | Investigate the total duration of the operation (surgical time data) of each patient | Up to 1 year | |
Primary | Perioperative Outcomes investigating the length of hospitalization | Investigate the length of hospitalization for each patient | Up to 1 year | |
Secondary | Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey | Surgery Task Load Index (SURG-TLX) survey from each surgeon performing surgery. | Up to 1 year | |
Secondary | Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire | Musculo-Skeletal Questionnaire (NMSQ) from each surgeon performing surgery. | Up to 1 year | |
Secondary | 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. | Up to 1 year | |
Secondary | 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. | Up to 1 year |
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