Breast Cancer, Breast Reconstruction, Hereditary Breast/Ovarian Cancer (brca1, brca2), Robotic Surgery
Conditions
Brief summary
This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction. There are different ways to perform a mastectomy. In some patients, a nipple-sparing mastectomy may be suitable, where the nipple and surrounding breast skin are preserved. This approach allows for immediate breast reconstruction with an implant, which is placed at the same time as the mastectomy to restore the breast shape. A newer technique called robotic single-port nipple-sparing mastectomy uses advanced robotic technology to remove breast tissue through a small hidden incision at the side of the chest. This method may reduce scarring, pain, and recovery time, while preserving the appearance and sensation of the breast. However, while early studies suggest this technique is safe and effective, more evidence is needed to compare it directly with standard surgeries. This study will compare: * Robotic nipple-sparing mastectomy * Standard (open) nipple-sparing mastectomy We will assess patient satisfaction, body image, physical and emotional well-being, and surgical outcomes over 12 months following surgery. By taking part, you are helping researchers evaluate whether robotic and nipple-sparing approaches offer measurable benefits to patients. Taking part in this study will not affect your surgery or the care you receive. You will be given the best treatment available based on your individual medical needs, whether or not you decide to participate in the research.
Interventions
PROCEDUREIntervention
Single-port robotic nipple-sparing mastectomy with immediately implant based reconstruction.
PROCEDUREStandard open nipple sparing mastectomy with immediate implant-based reconstruction
Standard open nipple sparing mastectomy with immediate implant-based reconstruction
Sponsors
Royal College of Surgeons, Ireland
Beaumont Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women aged 18 years and older * Candidates who have already been selected to undergo nipple sparing mastectomy and immediate implant reconstruction by the breast MDT for the following indications: * Genetic mutation carriers undergoing risk-reducing mastectomy. * Ductal carcinoma in situ (DCIS) requiring mastectomy. * Early invasive breast cancer requiring mastectomy. * The tumour must not have skin involvement and no evidence of invasive disease within 1cm of skin, nipple or Pec major muscle (as proven on MRI). * Candidates for immediate breast reconstruction with IMPLANT reconstruction * Fluent in English * Fit for general anaesthetic * Signed informed consent form
Exclusion criteria
* Advanced breast cancer with skin involvement. * Nipple involvement for Nipple Sparing Mastectomy Arms. * Prior chest wall radiation therapy * Pregnancy * Lactation * Patients with insufficient English to sign an informed consent (i.e. interpreter required).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measures | 1 year | * Surgical complication rates within 30 and 90 days, classified according to the Clavien-Dindo system. * Reoperation rates and need for unplanned return to theatre. * Length of hospital stay and drain duration * Operative time and estimated intraoperative blood loss. * Time to return to daily activities including work and physical exercise. * Aesthetic outcomes, assessed both by patient-reported satisfaction and by an independent panel review of standardized postoperative photographs. * Oncologic outcomes, including final pathology margin status and local recurrence (if applicable during follow-up). * Amount of residual breast tissue left on post operative MRI at 6 months in the different groups. |
| Primary Outcome Measure | 1 year | The primary endpoint of this study is the difference Breast Q scores at 12 months. |
Contacts
Primary ContactTrudi Roche Nelson, ANP RGN MSC
Outcome results
None listed