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Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy

NCT04151368 · University Health Network, Toronto · Updated 31 Jan 2025

What is being tested
Robotic Nipple-Sparing Mastectomy (RNSM)
For
Breast Cancer; Surgery--Complications; Genetic Predisposition to Disease; Surgery; BRCA1 Mutation; BRCA2 Mutation; Breast Diseases
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 20 years to 75 years. About 30 people. The full rules are on the registry page.
Where
Canada
When
Starts or started 1 Nov 2019, ends Dec 2025. Registered 5 Nov 2019.
Results
None posted yet.

In the researchers' words

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 centers 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…
ClinicalTrials.gov, NCT04151368

Sites

  • University Health NetworkToronto, Ontario, Canada