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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-05349 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (RNSM, surveys) | Experimental | RNMS Surveys |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted Nipple Sparing Mastectomy | Procedure | Under RNSM |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Complication rate of patients with bleeding requiring re-operation | Number of patients with bleeding requiring re-operation after RNSM. | 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. | 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. | Up to 1 year |
| Perioperative Outcomes investigating the total duration of surgical time | Investigate the total duration of the operation (surgical time data), | Up to 1 year |
| Perioperative Outcomes investigating length of surgery time | Investigate the total duration of the operation (surgical time data) of each patient | Up to 1 year |
| Perioperative Outcomes investigating the length of hospitalization | Investigate the length of hospitalization for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire |
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Inclusion Criteria:
Surgical candidates, per standard of care for:
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:
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)
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| Name | Affiliation | Role |
|---|---|---|
| William Carson, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34782341 | Derived | Park KU, Lee S, Sarna A, Chetta M, Schulz S, Agnese D, Grignol V, Carson W, Skoracki RJ. Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM). BMJ Open. 2021 Nov 15;11(11):e050173. doi: 10.1136/bmjopen-2021-050173. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| Survey Administration |
| Other |
ancillary correlative |
|
| RNSM | Device | Robot-assisted Nipple Sparing Mastectomy |
|
| Up to 1 year |
Musculo-Skeletal Questionnaire (NMSQ) from each surgeon performing surgery.
| 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. | 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. | Up to 1 year |
| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
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