NCT07236359Not yet recruiting
Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction
A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 13 Nov 2025
- Start date
- 31 Dec 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Beaumont Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT07236359
What you commit to
- Study type: Interventional
- Planned participants: 108
- From 31 Dec 2025 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior chest wall radiation therapy
Other illness
- Advanced breast cancer with skin involvement.
Other
- Nipple involvement for Nipple Sparing Mastectomy Arms.
- Pregnancy
- Lactation
- Patients with insufficient English to sign an informed consent (i.e. interpreter required).
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.