Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction (Reborn-i)

November 14, 2025 updated by: Arnold Hill, Beaumont Hospital

A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction

This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction. There are different ways to perform a mastectomy. In some patients, a nipple-sparing mastectomy may be suitable, where the nipple and surrounding breast skin are preserved. This approach allows for immediate breast reconstruction with an implant, which is placed at the same time as the mastectomy to restore the breast shape. A newer technique called robotic single-port nipple-sparing mastectomy uses advanced robotic technology to remove breast tissue through a small hidden incision at the side of the chest. This method may reduce scarring, pain, and recovery time, while preserving the appearance and sensation of the breast.

However, while early studies suggest this technique is safe and effective, more evidence is needed to compare it directly with standard surgeries.

This study will compare:

  • Robotic nipple-sparing mastectomy
  • Standard (open) nipple-sparing mastectomy We will assess patient satisfaction, body image, physical and emotional well-being, and surgical outcomes over 12 months following surgery. By taking part, you are helping researchers evaluate whether robotic and nipple-sparing approaches offer measurable benefits to patients.

Taking part in this study will not affect your surgery or the care you receive. You will be given the best treatment available based on your individual medical needs, whether or not you decide to participate in the research.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trudi Roche Nelson, ANP RGN MSC
  • Phone Number: +35318093000
  • Email: troche@rcsi.ie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 18 years and older
  • Candidates who have already been selected to undergo nipple sparing mastectomy and immediate implant 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.
  • 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 IMPLANT reconstruction
  • Fluent in English
  • Fit for general anaesthetic
  • Signed informed consent form

Exclusion Criteria:

  • Advanced breast cancer with skin involvement.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-port robotic nipple-sparing mastectomy with immediately implant based reconstruction.
Intervention
Procedure: Intervention
Single-port robotic nipple-sparing mastectomy with immediately implant based reconstruction.
Active Comparator: Standard open nipple sparing mastectomy with immediate implant-based reconstruction.
Standard of care
Procedure: Standard open nipple sparing mastectomy with immediate implant-based reconstruction
Standard open nipple sparing mastectomy with immediate implant-based reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome Measures
Time Frame: 1 year
  • Surgical complication rates within 30 and 90 days, classified according to the Clavien-Dindo system.
  • Reoperation rates and need for unplanned return to theatre.
  • Length of hospital stay and drain duration
  • Operative time and estimated intraoperative blood loss.
  • Time to return to daily activities including work and physical exercise.
  • Aesthetic outcomes, assessed both by patient-reported satisfaction and by an independent panel review of standardized postoperative photographs.
  • Oncologic outcomes, including final pathology margin status and local recurrence (if applicable during follow-up).
  • Amount of residual breast tissue left on post operative MRI at 6 months in the different groups.
1 year
Primary Outcome Measure
Time Frame: 1 year
The primary endpoint of this study is the difference Breast Q scores at 12 months.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beaumont Hospital

Collaborators

Royal College of Surgeons, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/72

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Protocol and anonymous study data will be shared through peer reviewed publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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