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Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction

RecruitingNAAges 18 Years - anyFemaleBeaumont Hospital
NCT07230535 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Nipple-sparing mastectomy (NSM) preserves the nipple-areolar complex (NAC) and is associated with improved cosmetic outcomes, body image, and patient satisfaction compared with more ablative techniques. Its use has expanded in both therapeutic and risk-reducing settings, including ductal carcinoma in situ (DCIS) and early-stage invasive breast cancer, where the NAC is not clinically or radiologically involved. Multiple observational and cohort studies support the oncological safety of NSM in appropriately selected patients, provided meticulous surgical technique and pathological assessment are employed to minimise the risk of residual disease. Robotic-assisted NSM has emerged as a minimally invasive alternative to conventional open techniques. Robotic platforms offer enhanced three-dimensional visualisation, improved instrument articulation, and ergonomic advantages that may facilitate

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📋 Eligibility rules (as published)
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).
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What it tests

  • Robotic Assisted Nipple Sparing Mastectomy
  • Standarding Open Nipple Sparing Mastectomy
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Where

1 site
Beaumont RCSI Cancer Centre
Beaumont, Ireland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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