- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04151368
Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy (RNSM)
Robotic Nipple-Sparing Mastectomy With Immediate Prosthetic Breast Reconstruction: Prospective Study of Feasibility, Safety and Patient Satisfaction, Toronto Experience.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G2C4
- University Health Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Robotic Nipple Sparing Mastectomy Arm
Patient cohort undergoing nipple sparing mastectomy with use of robotic dissection.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of RNSM
Time Frame: 1 month
|
Surgical time in minutes
|
1 month
|
Wound complications
Time Frame: 2 months
|
Skin and Nipple necrosis
|
2 months
|
Margins after RNSM
Time Frame: 1 month
|
Margin status (mm)
|
1 month
|
Breast cancer recurrence
Time Frame: 36 months
|
Site of first relapse
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Pre-Operative and 6 and 12 months post-operative
|
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.
|
6 months post-operative
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tulin D Cil, MD, MEd, University Health Network, Toronto
Publications and helpful links
General Publications
- Toesca A, Peradze N, Manconi A, Galimberti V, Intra M, Colleoni M, Bonanni B, Curigliano G, Rietjens M, Viale G, Sacchini V, Veronesi P. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast. 2017 Feb;31:51-56. doi: 10.1016/j.breast.2016.10.009. Epub 2016 Nov 2.
- Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-5250.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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