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

NCT07230535 | Recruiting

• 1 other identifier: 25/56
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Robotic Surgery; Breast Reconstruction; DIEP Flap Breast Reconstruction; Breast Cancer, Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this study is the difference in patient-reported outcomes at 12 months postoperatively.

  Difference in patient-reported outcomes at 12 months postoperatively, assessed using the BREAST-Q Reconstruction Module

  Up to 12 months post operative

Study Arms (2)

Robotic Assisted Nipple Sparing Mastectomy

EXPERIMENTAL

Participants randomised to this arm will undergo robotic-assisted nipple-sparing mastectomy using a single-port robotic platform. Surgery will be performed via a single axillary incision. Immediate breast reconstruction will be undertaken according to the pre-specified reconstruction plan: Implant-based reconstruction or Autologous deep inferior epigastric perforator (DIEP) flap reconstruction Robotic-assisted procedures will be delivered at the designated network hub hospital.

Procedure: Robotic Assisted Nipple Sparing Mastectomy

Standard Open Nipple Sparing Mastectomy

ACTIVE COMPARATOR

Participants randomised to this arm will undergo standard open nipple-sparing mastectomy performed via a conventional incision in accordance with institutional practice. Immediate breast reconstruction will be undertaken according to the pre-specified reconstruction plan: Implant-based reconstruction or Autologous deep inferior epigastric perforator (DIEP) flap reconstruction Standard open procedures will be performed either at the referring network site or centrally, depending on reconstructive requirements.

Procedure: Standarding Open Nipple Sparing Mastectomy

Interventions

Robotic Assisted Nipple Sparing Mastectomy PROCEDURE

Description: Nipple-sparing mastectomy performed using a single-port robotic surgical system through a single axillary incision, preserving the nipple-areolar complex where oncologically appropriate.

Robotic Assisted Nipple Sparing Mastectomy

Standarding Open Nipple Sparing Mastectomy PROCEDURE

Nipple-sparing mastectomy performed using an open surgical approach through a conventional incision, preserving the nipple-areolar complex where oncologically appropriate.

Standard Open Nipple Sparing Mastectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Genetic mutation carriers undergoing risk-reducing mastectomy.
• Ductal carcinoma in situ (DCIS) requiring mastectomy.
• Early invasive breast cancer requiring mastectomy.
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beaumont Hospital: lead

Study Sites (1)

Beaumont RCSI Cancer Centre

Beaumont, D09, Ireland

RECRUITING

Related Publications (1)

• Toesca A, Sangalli C, Maisonneuve P, Massari G, Girardi A, Baker JL, Lissidini G, Invento A, Farante G, Corso G, Rietjens M, Peradze N, Gottardi A, Magnoni F, Bottiglieri L, Lazzeroni M, Montagna E, Labo P, Orecchia R, Galimberti V, Intra M, Sacchini V, Veronesi P. A Randomized Trial of Robotic Mastectomy Versus Open Surgery in Women With Breast Cancer or BrCA Mutation. Ann Surg. 2022 Jul 1;276(1):11-19. doi: 10.1097/SLA.0000000000004969. Epub 2021 Jun 9.

  PMID: 34597010 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Trudi Nelson Roche

CONTACT

003531; troche@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: Peer review publications

Locations

IE (1)