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

NCT07230535 · Beaumont Hospital · Updated 1 June 2026

What is being tested
Robotic Assisted Nipple Sparing Mastectomy; Standarding Open Nipple Sparing Mastectomy
For
Breast Cancer, Breast Neoplasms; Breast Reconstruction; DIEP Flap Breast Reconstruction; Robotic Surgery
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 250 people. The full rules are on the registry page.
Where
Ireland
When
Starts or started 1 Dec 2025, ends 31 Dec 2029. Registered 17 Nov 2025.
Results
None posted yet.

In the researchers' words

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 precise dissection while reducing surgeon fatigue. Single-port robotic systems enable NSM to be performed through a single axillary incision, potentially reducing visible scarring and postoperative discomfort while maintaining oncological principles. Early series from high-volume centres have demonstrated the technical feasibility and short-term safety of robotic NSM, with outcomes broadly comparable to open NSM and signals of potential aesthetic benefit. However, these data are largely…
ClinicalTrials.gov, NCT07230535

Sites

  • Beaumont RCSI Cancer CentreBeaumont, Ireland