Finding studies
Finding studies
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Lead
University Health Network, Toronto
This is a single-arm prospective study to assess feasibility and safety (primary outcomes), as well as patient satisfaction, cosmetic and oncologic outcomes of RNSM-IPBR in women with BC or at high risk of BC treated at UHN. The objectives of the study are to determine: 1. Feasibility of RNSM-IPBR through assessing operative parameters (such as time of procedure, robot docking time, conversion to conventional NSM-IPBR). 2. Safety of RNSM-IPBR through assessing rate of morbidity from surgical complications (such as wound infection, flap and NAC necrosis, postoperative hematoma/bleeding, seroma requiring aspiration, implant loss, anesthesia related complications and need for reoperation with one month due to complications) and mortality due to the procedure. 3. Patient satisfaction from RNSM-IPBR through assessing psychological, physical, sexual well-being, as well as satisfaction with breast, overall outcome and care through patient reported outcomes. 4. Cosmetic outcomes of RNSM-IPBR, such as distortion or malposition of NAC and scarring, rate of reoperation due to unacceptable cosmetic outcomes. 5. Short- and long-term oncologic outcomes of NSM-IPBR, such as positivity of margins, breast cancer incidence and recurrence rate, as well as overall survival. The rationale of the study is to investigate a novel technique of RNSM-IPBR that might have superior cosmetic and patient satisfaction outcomes, as well as lower rates of complications, based on a small number of previously published studies from Europe and Asia. Once enrolled, clinical, radiologic, and pathologic data will be collected for each participant at the initial visit and follow up data will be collected via available electronic patient records. RNSM-IPBR will be performed by previously described method (Toesca et al.) using an extra-mammary axillary incision along the mid-axillary line in the axillary fossa. We will use Da Vinci Si Surgical System® (Intuitive Surgical, Sunnyvale, CA) available at Toronto General Hospital, UHN.
Age
20–75
Sex
FEMALE
Healthy volunteers
Not accepted
