Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07230535

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

Led by Beaumont Hospital · Updated on 2026-01-07

250

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 non-randomised and derived from single-centre experiences. Despite the increasing adoption of both conventional and robotic NSM, there remains a paucity of high-quality prospective evidence evaluating patient-reported outcomes (PROs). Validated instruments such as the Breast-Q, Hopwood Body Image Scale, and Aesthetic Item Scale (AIS) provide robust measures of patient satisfaction, psychosocial well-being, and aesthetic outcome, yet randomised comparisons of robotic versus open NSM using these tools are lacking. In particular, there is limited evidence examining whether the proposed cosmetic and experiential advantages of robotic surgery translate into meaningful improvements in PROs across different reconstructive pathways. Breast reconstruction is a critical determinant of postoperative quality of life following mastectomy. Both implant-based reconstruction and autologous reconstruction using deep inferior epigastric perforator (DIEP) flaps are established techniques, each with distinct risk profiles, recovery trajectories, and long-term outcomes. Autologous DIEP reconstruction is associated with superior long-term satisfaction and physical well-being in many patients, while implant-based reconstruction remains the most commonly performed approach nationally. Evaluating NSM techniques across both reconstructive modalities enhances the generalisability and clinical relevance of trial findings. The REBORN Network Trial is a multicentre, randomised controlled study conducted within an Irish cancer network using a hub-and-spoke model for robotic surgery delivery. Patients undergoing mastectomy with immediate reconstruction are stratified by reconstruction type (implant-based or DIEP flap) and randomised to receive either robotic-assisted or conventional open NSM. Robotic procedures are centralised within a designated surgical hub, while open procedures are delivered either locally or centrally, depending on reconstructive requirements. This design enables equitable access to robotic surgery while maintaining oncological safety and surgical expertise. By comparing robotic-assisted and open NSM within both implant and DIEP reconstruction cohorts using validated PRO measures, this study aims to determine whether robotic technology confers measurable benefits in patient satisfaction, body image, and aesthetic outcome. The findings will inform patient counselling, surgical decision-making, and future service development within networked breast cancer care systems.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 years and older
  • Selected for mastectomy and immediate DIEP reconstruction by breast MDT
  • Indications include genetic mutation carriers for risk-reducing mastectomy, DCIS requiring mastectomy, or early invasive breast cancer
  • Tumor must not involve skin, nipple, or be within 1cm of nipple or Pec major muscle for NSM arms
  • Candidates for immediate DIEP reconstruction
  • Fluent in English
  • Fit for general anaesthetic
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Advanced breast cancer with skin involvement for NSM arms
  • Nipple involvement for NSM arms
  • Prior chest wall radiation therapy
  • Pregnancy
  • Lactation
  • Insufficient English to provide informed consent (interpreter required)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beaumont RCSI Cancer Centre

Beaumont, Ireland, D09

Actively Recruiting

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Research Team

T

Trudi Nelson Roche

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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