Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention, Standard open nipple sparing mastectomy with immediate implant-based reconstruction.
- Who it may be relevant to
- Registry conditions: Breast Reconstruction, Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Robotic Surgery. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction
Overview
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
- Procedure Intervention
Single-port robotic nipple-sparing mastectomy with immediately implant based reconstruction. - Procedure Standard open nipple sparing mastectomy with immediate implant-based reconstruction
Standard open nipple sparing mastectomy with immediate implant-based reconstruction
Primary outcome measures
- Secondary Outcome Measures [Time frame: 1 year]
- Primary Outcome Measure [Time frame: 1 year]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Toesca A, Sangalli C, Maisonneuve P, Massari G, Girardi A, Baker JL, Lissidini G, Invento A, Farante G, Corso G, Rietjens M, Peradze N, Gottardi A, Magnoni F, Bottiglieri L, Lazzeroni M, Montagna E, Labo P, Orecchia R, Galimberti V, Intra M, Sacchini V, Veronesi P. A Randomized Trial of Robotic Mastectomy Versus Open Surgery in Women With Breast Cancer or BrCA Mutation. Ann Surg. 2022 Jul 1;276(1) PMID 34597010
- Sarfati B, Honart JF, Leymarie N, Rimareix F, Al Khashnam H, Kolb F. Robotic da Vinci Xi-assisted nipple-sparing mastectomy: First clinical report. Breast J. 2018 May;24(3):373-376. doi: 10.1111/tbj.12937. Epub 2017 Dec 18. PMID 29251382
Identifiers
NCT: NCT07236359 · 25/72