Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy (RNSM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04151368|
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Surgery--Complications Genetic Predisposition to Disease Surgery BRCA1 Mutation BRCA2 Mutation Breast Diseases||Procedure: Robotic Nipple-Sparing Mastectomy (RNSM)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective Single Arm|
|Masking:||None (Open Label)|
|Official Title:||Robotic Nipple-Sparing Mastectomy With Immediate Prosthetic Breast Reconstruction: Prospective Study of Feasibility, Safety and Patient Satisfaction, Toronto Experience.|
|Actual Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||November 1, 2022|
Experimental: Robotic Nipple Sparing Mastectomy Arm
Patient cohort undergoing nipple sparing mastectomy with use of robotic dissection.
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).
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04151368
|Contact: Tulin D Cil, MD, MEd||(416) 946-4501 ext firstname.lastname@example.org|
|Contact: Armen Parsyan, MD, PhDemail@example.com|
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G2C4|
|Contact: Tulin Cil, MD 4169464501 ext 3984 firstname.lastname@example.org|
|Contact: Anne O'Neill, MD 416340-3143 email@example.com|
|Sub-Investigator: David R. McCready, MD|
|Sub-Investigator: Stefan Hofer, MD|
|Principal Investigator:||Tulin D Cil, MD, MEd||University Health Network, Toronto|