Breast Cancer, Breast NeoplasmsREBORNNCT07230535
Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction
A study testing Robotic Assisted Nipple Sparing Mastectomy and Standarding Open Nipple Sparing Mastectomy in people with Breast Cancer, Breast Neoplasms and Breast Reconstruction, run by Beaumont Hospital at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Reconstruction, DIEP Flap Breast Reconstruction
- What is being tested?
- Robotic Assisted Nipple Sparing Mastectomy and Standarding Open Nipple Sparing Mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIreland
- Study dates
- 1 Dec 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 10Show fewer
- Candidates for immediate breast reconstruction with DIEP reconstruction
- Fluent in English
- Fit for general anaesthetic
- Signed informed consent form
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Beaumont RCSI Cancer Centre
Beaumont, D09
Arnold DK Hill, 017977800, arnoldhill@beaumont.ie
About this study
Official title: A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Open vs Robotic Single-port Nipple Sparing Mastectomy With DIEP Reconstruction
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.
Read more
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.
Read the detailed description
The study will be a prospective, multicentre, single-blinded (outcome assessor-blinded), randomised controlled trial conducted within an Irish cancer network using a hub-and-spoke model for robotic surgery delivery. The trial will compare robotic-assisted versus conventional open nipple-sparing mastectomy (NSM) in patients undergoing immediate breast reconstruction.
Participants will be stratified by type of reconstruction and randomised in a 1:1 ratio within each stratum. Two reconstruction cohorts will be studied:
Implant Reconstruction Cohort Arm A1: Robotic-assisted NSM with immediate implant-based reconstruction Arm A2: Standard open NSM with immediate implant-based reconstruction
Autologous Reconstruction (DIEP) Cohort
Arm B1: Robotic-assisted NSM with immediate DIEP flap reconstruction Arm B2: Standard open NSM with immediate DIEP flap reconstruction
Randomisation will be stratified by recruiting site and reconstruction type. Robotic-assisted NSM procedures will be performed at the designated network hub, while standard open NSM procedures will be undertaken either at the referring site or centrally, depending on reconstructive requirements.
All patients eligible for mastectomy and immediate reconstruction will be screened for inclusion. Eligibility for nipple-sparing mastectomy will be determined based on clinical and radiological criteria, including the absence of tumour involvement of the skin or nipple-areolar complex and an adequate tumour-to-nipple distance, in accordance with institutional and national guidelines. Patients not suitable for NSM will not be randomised and will undergo standard-of-care mastectomy outside the trial.
Blinding will be applied to outcome assessment. Independent assessors evaluating aesthetic outcomes and analysing patient-reported outcome measures, including Breast-Q, Hopwood Body Image Scale, and Aesthetic Item Scale (AIS), will be blinded to treatment allocation. Due to the nature of the surgical interventions, blinding of patients and surgeons will not be feasible.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Reconstruction, DIEP Flap Breast Reconstruction, Robotic Surgery
- Being tested
- Robotic Assisted Nipple Sparing Mastectomy, Standarding Open Nipple Sparing Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted Nipple Sparing MastectomyProcedure or surgery
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.
Standarding Open Nipple Sparing MastectomyProcedure or surgery
Nipple-sparing mastectomy performed using an open surgical approach through a conventional incision, preserving the nipple-areolar complex where oncologically appropriate.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standarding Open Nipple Sparing Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer, Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnold Hill, Royal College of Surgeons, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230535
- Sponsor's protocol ID
- 25/56
- Acronym
- REBORN
- Status last verified
- May 2026
- First submitted
- 13 Nov 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and anonymised data related to the results will be made available through peer review publication.
Publications
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.
PubMed 34597010
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Open vs Robotic Single-port Nipple Sparing Mastectomy With DIEP Reconstruction
- ClinicalTrials.gov ID
- NCT07230535
- Acronym / sponsor ID
- REBORN / 25/56
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Reconstruction, DIEP Flap Breast Reconstruction, Robotic Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be a prospective, multicentre, single-blinded (outcome assessor-blinded), randomised controlled trial conducted within an Irish cancer network using a hub-and-spoke model for robotic surgery delivery. The trial will compare robotic-assisted versus conventional open nipple-sparing mastectomy (NSM) in patients undergoing immediate breast reconstruction.
Participants will be stratified by type of reconstruction and randomised in a 1:1 ratio within each stratum. Two reconstruction cohorts will be studied:
Implant Reconstruction Cohort Arm A1: Robotic-assisted NSM with immediate implant-based reconstruction Arm A2: Standard open NSM with immediate implant-based reconstruction
Autologous Reconstruction (DIEP) Cohort
Arm B1: Robotic-assisted NSM with immediate DIEP flap reconstruction Arm B2: Standard open NSM with immediate DIEP flap reconstruction
Randomisation will be stratified by recruiting site and reconstruction type. Robotic-assisted NSM procedures will be performed at the designated network hub, while standard open NSM procedures will be undertaken either at the referring site or centrally, depending on reconstructive requirements.
All patients eligible for mastectomy and immediate reconstruction will be screened for inclusion. Eligibility for nipple-sparing mastectomy will be determined based on clinical and radiological criteria, including the absence of tumour involvement of the skin or nipple-areolar complex and an adequate tumour-to-nipple distance, in accordance with institutional and national guidelines. Patients not suitable for NSM will not be randomised and will undergo standard-of-care mastectomy outside the trial.
Blinding will be applied to outcome assessment. Independent assessors evaluating aesthetic outcomes and analysing patient-reported outcome measures, including Breast-Q, Hopwood Body Image Scale, and Aesthetic Item Scale (AIS), will be blinded to treatment allocation. Due to the nature of the surgical interventions, blinding of patients and surgeons will not be feasible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Assisted Nipple Sparing Mastectomy | Experimental | Procedure: Robotic Assisted Nipple Sparing MastectomyParticipants 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. |
| Standard Open Nipple Sparing Mastectomy | Active comparator | Procedure: Standarding Open Nipple Sparing MastectomyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Candidates for immediate breast reconstruction with DIEP reconstruction
- Fluent in English
- Fit for general anaesthetic
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Assisted Nipple Sparing MastectomyDescription: Nipple-sparing mastectomy performed using a single-port robotic surgical system through a single axillary incision, preserving the nipple-areolar complex where oncologically appropriate. | Procedure or surgery | Robotic Assisted Nipple Sparing Mastectomy |
| Standarding Open Nipple Sparing MastectomyNipple-sparing mastectomy performed using an open surgical approach through a conventional incision, preserving the nipple-areolar complex where oncologically appropriate. | Procedure or surgery | Standard Open Nipple Sparing Mastectomy |
Primary outcome
The primary endpoint of this study is the difference in patient-reported outcomes at 12 months postoperatively.
Time frame: Up to 12 months post operative
Difference in patient-reported outcomes at 12 months postoperatively, assessed using the BREAST-Q Reconstruction Module
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 34597010Toesca 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.
- Individual participant dataSharing planned: Yes. Study protocol and anonymised data related to the results will be made available through peer review publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Assisted Nipple Sparing Mastectomy and Standarding Open Nipple Sparing Mastectomy in people with Breast Cancer, Breast Neoplasms and Breast Reconstruction, run by Beaumont Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trudi Nelson Roche (003531, troche@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this study is the difference in patient-reported outcomes at 12 months postoperatively. (time frame: Up to 12 months post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07230535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.