Official Title
Robotic Nipple-Sparing Mastectomy With Immediate Prosthetic Breast Reconstruction: Prospective Study of Feasibility, Safety and Patient Satisfaction, Toronto Experience.
Summary:
Nipple-sparing mastectomy (NSM) with immediate reconstruction is one of the standard of care
surgical treatments of breast cancer (BC) and is used for risk reduction in patients with a
high risk for BC. While this method shows satisfactory oncologic and good cosmetic outcomes,
its drawbacks include compromise of the skin flap vascularization due to skin incision,
nipple-areolar complex (NAC) malposition/distortion and visible scar on the breast. NSM also
has technical challenges of dissecting and removing larger specimens through limited
incisions and concerns regarding oncologic effectiveness due to difficulties in visualizing
regions of the breast remote from the incision. To improve cosmetic outcomes after NSM, a
modification of this technique using a surgical robotic system was recently described. In a
limited number of studies, the robotic NSM (RNSM) with immediate prosthetic breast
reconstruction (IPBR) was shown to be feasible and safe, as well as led to excellent cosmetic
outcomes and patient satisfaction. There are limited number of centres in North America and
none in Canada that offer RNSM-IPBR. The investigators hypothesize that RNSM-IPBR is a
feasible and safe technique that can be utilized in our institution and that it can provide
superior cosmetic outcomes with less morbidity and higher patient satisfaction compared to
the traditional NSM-IPBR. The aim is to conduct a single-arm prospective study to investigate
the safety and feasibility, as well as cosmetic, surgical complication and patient
satisfaction parameters of NSM-IPBR performed in the University Health Network (UHN). This
study will serve a foundation for potential introduction of a novel surgical approach in our
institution and will make it available for treatment and prevention of breast cancer in
Canadian women. The study will also serve as pilot data for future potential studies,
including randomized-controlled trials (RCT) comparing RNSM with conventional NSM. As such,
the study will further our approach to innovation in breast surgical oncology within Canada
and North America.
Trial Description
Primary Outcome:
- Feasibility of RNSM
- Wound complications
- Margins after RNSM
- Breast cancer recurrence
Secondary Outcome:
- Patient Satisfaction
- Body Image
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:
·
Feasibility of RNSM-IPBR through assessing
operative parameters (such as time of procedure, robot docking time, conversion
to conventional NSM-IPBR).
·
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.
·
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.
·
Cosmetic outcomes of RNSM-IPBR, such as
distortion or malposition of NAC and scarring, rate of reoperation due to
unacceptable cosmetic outcomes.
·
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.
View this trial on ClinicalTrials.gov
