Open versus robotic nipple-sparing mastectomy with immediate DIEP or implant reconstruction
A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Open vs Robotic Single-port Nipple Sparing Mastectomy With DIEP Reconstruction
This trial will test whether robotic-assisted nipple-sparing mastectomy leads to better wellbeing and patient-reported outcomes than standard open nipple-sparing mastectomy in adults having immediate implant or DIEP flap breast reconstruction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Beaumont Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beaumont) |
| Trial ID | NCT07230535 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicentre, single-blinded randomized trial using a hub-and-spoke model within an Irish cancer network to compare robotic-assisted versus standard open nipple-sparing mastectomy with immediate reconstruction. Participants are stratified by reconstruction type (implant or DIEP) and by site, then randomized 1:1 within each stratum to robotic or open approaches. Robotic procedures are performed at designated hub centres while open procedures occur at the referring site or centrally depending on reconstructive needs, and outcome assessors are blinded to allocation. The trial focuses on patient-reported wellbeing and other PROMs alongside surgical and short-term clinical outcomes.
Who should consider this trial
Good fit: Adult women selected by their multidisciplinary team for mastectomy with immediate DIEP or implant reconstruction who are eligible for nipple-sparing mastectomy (no skin or nipple involvement), fit for general anaesthesia, and able to consent and communicate in English are ideal candidates.
Not a fit: Patients with advanced disease involving the skin or nipple, prior chest wall radiotherapy, pregnant or lactating women, or those not eligible for nipple-sparing mastectomy are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, robotic-assisted nipple-sparing mastectomy could improve cosmetic results, body image, and overall quality of life while potentially reducing surgical trauma and recovery time.
How similar studies have performed: Observational and cohort data support the oncologic safety and improved cosmetic outcomes of nipple-sparing mastectomy, but randomized comparisons of robotic-assisted versus open approaches are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 18 years and older * Candidates who have already been selected to undergo mastectomy (of any kind) and immediate DIEP reconstruction by the breast MDT for the following indications: 1. Genetic mutation carriers undergoing risk-reducing mastectomy. 2. Ductal carcinoma in situ (DCIS) requiring mastectomy. 3. Early invasive breast cancer requiring mastectomy. 4. For those considered for Nipple Sparing Mastectomy randomisation arms 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 DIEP reconstruction * Fluent in English * Fit for general anaesthetic * Signed informed consent form Exclusion Criteria: * Advanced breast cancer with skin involvement for Nipple Sparing Mastectomy Arms * 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).
Where this trial is running
Beaumont
- Beaumont RCSI Cancer Centre — Beaumont, Ireland (Recruiting)
Study contacts
- Study coordinator: Trudi Nelson Roche
- Email: troche@rcsi.ie
- Phone: 003531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.