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

Beaumont Hospital

Status: Not yet enrolling

Conditions: Breast Cancer; Breast Reconstruction; Hereditary Breast/Ovarian Cancer (brca1, brca2); Robotic Surgery

Treatments: Procedure: Intervention; Procedure: Standard open nipple sparing mastectomy with immediate implant-based reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT07236359

25/72

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

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

Experimental group

Description:

Intervention

Treatment:

Procedure: Intervention

Standard open nipple sparing mastectomy with immediate implant-based reconstruction.

Active Comparator group

Description:

Standard of care

Treatment:

Procedure: Standard open nipple sparing mastectomy with immediate implant-based reconstruction