Open versus robotic nipple-sparing mastectomy with immediate DIEP or implant reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beaumont RCSI Cancer Centre
  Beaumont, Ireland Recruiting

Study contacts

• Study coordinator: Trudi Nelson Roche
• Email: troche@rcsi.ie
• Phone: 003531

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.