This clinical trial evaluates safety and feasibility of utilizing the da Vinci single-port robot for the robotic nipple sparing mastectomy and immediate breast reconstruction with tissue expanders/implants in either patients with an existing breast cancer or those at high-risk for developing breast cancer. Breast cancer treatments have made significant advances over the last few years, but however, survival is no longer the only goal on the cancer patients’ minds. Preservation and/or restoration of physical appearance and self-image are becoming significant topics in breast cancer literature. Skin sparing and nipple sparing mastectomies are two operations developed which have improved overall patient satisfaction and cosmetic outcomes post breast cancer surgery. The use of a surgical robot with four “arms” (multi-port) has been utilized in several centers outside of the United States as an acceptable alternative to the standard open surgical approach. Benefits of robotic nipple sparing mastectomy(s) and immediate breast reconstruction with prosthesis are several, including improved circulation of the nipple, improved operative precision, as well as a single, small scar. However, since this a new procedure, long-term outcomes associated with cancer recurrence across a large population are still being evaluated. This trial is being done to learn the outcomes after robotic single-port nipple sparing mastectomy and immediate breast reconstruction. The single-port system may allow for an even smaller incision and the ability to remove lymph nodes from the same location.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05245812.
Locations matching your search criteria
United States
Texas
Dallas
UT Southwestern/Simmons Cancer Center-DallasStatus: Active
Contact: Deborah E. Farr
Phone: 214-648-5870
PRIMARY OBJECTIVES:
I. To determine feasibility as measured by: a) completion of single port nipple sparing mastectomy (SPrNSM) as determined by number of patients who completed surgery with en bloc removal of the breast through axillary incision compared to conversion to an open incision and b) operative time.
II. To determine safety as measured by incidence of intraoperative and post-operative adverse events assessed from date of surgery to 30 days after surgery.
SECONDARY OBJECTIVES:
I. To assess oncologic outcomes as measured by: a) rate of margin positivity in patients undergoing SPrNSM for breast cancer and b) incidence of new and recurrent breast cancer through five years following date of surgery.
II. To determine patient reported outcomes as measured by BREAST-Q recon/sensation tool pre-operatively and post-operatively at 2 weeks, 6 months and annually through 5 years.
III. To determine nipple sensation outcomes as measured by the Semmes Weinstein monofilament tool pre-operatively and post-operatively at 2 weeks, 6 months and annually through 5 years.
IV. To determine reconstruction outcomes as measured by short term complications (wounds, infections, seromas, and device exchange or loss) and long-term complications.
OUTLINE:
Patients undergo SPrNSM using the da Vinci SP Surgical System with immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (Alloderm).
Patients are followed up at 2 weeks, 1 month, 2 months, and every 6 months for 5 years following date of surgery per standard of care follow-up following nipple sparing mastectomy.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorDeborah E. Farr
