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Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy

NCT04151368 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-31

No results posted yet for this study

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 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 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.

Conditions

  • Breast Cancer
  • Surgery--Complications
  • Genetic Predisposition to Disease
  • Surgery
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Breast Diseases

Interventions

PROCEDURE

Robotic Nipple-Sparing Mastectomy (RNSM)

RNSM will be performed by previously described method using 3 cm 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).

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Tulin D Cil, MD, MEd · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04151368 on ClinicalTrials.gov