Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBeaumont Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Women aged 18 years and older

Genetic mutation carriers undergoing risk-reducing mastectomy.

Ductal carcinoma in situ (DCIS) requiring mastectomy.

Early invasive breast cancer requiring mastectomy.

Disqualifiers

Advanced breast cancer with skin involvement.

Nipple involvement for Nipple Sparing Mastectomy Arms.

Prior chest wall radiation therapy

Pregnancy

Trial design

Treatments tested in this trial

  • Intervention
  • Standard open nipple sparing mastectomy with immediate implant-based reconstruction

Treatment groups

108 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Beaumont Hospital

Lead sponsor

Royal College of Surgeons, Ireland

Collaborator