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NCT Number: NCT07236359

Evaluation of 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.

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Key information

Conditions

Breast Reconstruction Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hereditary Breast and Ovarian Cancer Syndrome Hereditary Breast/Ovarian Cancer (brca1, brca2) Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Ovarian Diseases Ovarian Neoplasms Robotic Surgery Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intervention

Procedure

Single-port robotic nipple-sparing mastectomy with immediately implant based reconstruction.

Standard open nipple sparing mastectomy with immediate implant-based reconstruction

Procedure

Standard open nipple sparing mastectomy with immediate implant-based reconstruction

Primary outcomes

  1. 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.

  2. Primary Outcome Measure

    Time frame: 1 year

    The primary endpoint of this study is the difference Breast Q scores at 12 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Trudi Roche Nelson, ANP RGN MSC

CONTACT

[email protected]

+35318093000

Sponsors and collaborators

Lead sponsor

Beaumont Hospital

Other

Collaborators

  • Royal College of Surgeons, Ireland

Registry information

Official study title

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

Acronym: Reborn-i

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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