Clinical Trials /

Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy

NCT04151368

Description:

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.

Related Conditions:
  • Ductal Carcinoma In Situ
  • Hereditary Breast and Ovarian Cancer Syndrome
  • Invasive Breast Carcinoma
Recruiting Status:

Suspended

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT04151368

Trial Eligibility

Document

Title

  • Brief Title: Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy
  • Official Title: Robotic Nipple-Sparing Mastectomy With Immediate Prosthetic Breast Reconstruction: Prospective Study of Feasibility, Safety and Patient Satisfaction, Toronto Experience.

Clinical Trial IDs

  • ORG STUDY ID: 19-5250.0
  • NCT ID: NCT04151368

Conditions

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

Purpose

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.

Detailed Description

      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.

Trial Arms

NameTypeDescriptionInterventions
Robotic Nipple Sparing Mastectomy ArmExperimentalPatient cohort undergoing nipple sparing mastectomy with use of robotic dissection.

    Eligibility Criteria

            Inclusion Criteria:

          -  Women of any age with invasive breast cancer (BC), ductal carcinoma in situ (DCIS),
             BRCA or other breast cancer genetic mutation carriers or high risk BC female patients
             who are otherwise candidates for NSM with IPBR will be eligible for the study. For
             those patients, RNSM-IPBR will be offered. Those who, after thorough discussion of
             risks and benefits, choose and consent to undergo RNSM-IPBR will be included in the
             study.

        Exclusion Criteria:

          -  Heavy smokers (>20 cigarettes a day)

          -  Uncompensated Diabetes Mellitus

          -  High risk for anesthesia (ASA 4)

          -  Inflammatory Breast Cancer

          -  Previous thoracic radiation therapy for any reason

          -  Pregnancy

          -  Psychiatric, addictive, or any disorder which compromises ability to give informed
             consent for participation in this study
    Maximum Eligible Age:75 Years
    Minimum Eligible Age:20 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Feasibility of RNSM
    Time Frame:1 month
    Safety Issue:
    Description:Surgical time in minutes

    Secondary Outcome Measures

    Measure:Patient Satisfaction
    Time Frame:Pre-Operative and 6 and 12 months post-operative
    Safety Issue:
    Description:Breast Q Pre and Post-operative Surveys- items measuring satisfaction with appearance, surgical experience, breast shape and symmetry, psychosocial, physical and sexual well being. Lowest score = 0, highest = 100 with higher scores indicating better outcomes / quality of life.
    Measure:Body Image
    Time Frame:6 months post-operative
    Safety Issue:
    Description:Hopwood's Body Image Scale- Scores range from 0 (min distress) to 3 (max distress) for 10 questions. Lowest score = 0, highest = 30 with lower scores indicated lower body image distress.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Suspended
    Lead Sponsor:University Health Network, Toronto

    Trial Keywords

    • breast surgery
    • robotic surgery
    • nipple sparing mastectomy
    • genetic predisposition
    • breast cancer

    Last Updated

    April 22, 2021