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Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy (RNSM)

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ClinicalTrials.gov Identifier: NCT04151368
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE October 30, 2019
First Posted Date  ICMJE November 5, 2019
Last Update Posted Date November 20, 2019
Actual Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
  • Feasibility of RNSM [ Time Frame: 1 month ]
    Surgical time in minutes
  • Wound complications [ Time Frame: 2 months ]
    Skin and Nipple necrosis
  • Margins after RNSM [ Time Frame: 1 month ]
    Margin status (mm)
  • Breast cancer recurrence [ Time Frame: 36 months ]
    Site of first relapse
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2019)
  • Feasibility of RNSM [ Time Frame: 24 months ]
    Surgical time in minutes
  • Wound complications [ Time Frame: 24 months ]
    Skin and Nipple necrosis
  • Margins after RNSM [ Time Frame: 24 months ]
    Margin status (mm)
  • Breast cancer recurrence [ Time Frame: 24 months ]
    Site of first relapse
Change History Complete list of historical versions of study NCT04151368 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
  • Patient Satisfaction [ Time Frame: Pre-Operative and 6 and 12 months post-operative ]
    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.
  • Body Image [ Time Frame: 6 months post-operative ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2019)
  • Patient Satisfaction [ Time Frame: 24 months ]
    Breast Q
  • Patient reported outcome [ Time Frame: 24 months ]
    Hopwood Body Image Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy
Official Title  ICMJE Robotic Nipple-Sparing Mastectomy With Immediate Prosthetic Breast Reconstruction: Prospective Study of Feasibility, Safety and Patient Satisfaction, Toronto Experience.
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective Single Arm
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Surgery--Complications
  • Genetic Predisposition to Disease
  • Surgery
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Breast Diseases
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: Robotic Nipple Sparing Mastectomy Arm
Patient cohort undergoing nipple sparing mastectomy with use of robotic dissection.
Intervention: Procedure: Robotic Nipple-Sparing Mastectomy (RNSM)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2022
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female patients with increased lifetime risk of breast cancer Female patients with early stage breast cancer
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tulin D Cil, MD, MEd (416) 946-4501 ext 3984 tulin.cil@uhn.ca
Contact: Armen Parsyan, MD, PhD armen.parsyan@mail.mcgill.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04151368
Other Study ID Numbers  ICMJE 19-5250.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tulin D Cil, MD, MEd University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP