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

NCT ID: NCT07236359

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Intervention

Group Type: EXPERIMENTAL

Intervention

Intervention Type: PROCEDURE

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

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

Standard of care

Group Type: ACTIVE_COMPARATOR

Standard open nipple sparing mastectomy with immediate implant-based reconstruction

Intervention Type: PROCEDURE

Standard open nipple sparing mastectomy with immediate implant-based reconstruction

Interventions

Intervention

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

Intervention Type: PROCEDURE

Standard open nipple sparing mastectomy with immediate implant-based reconstruction

Standard open nipple sparing mastectomy with immediate implant-based reconstruction

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Royal College of Surgeons, Ireland

OTHER

Sponsor Role: collaborator

Beaumont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Arnold Hill

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Trudi Roche Nelson, ANP RGN MSC

Role: CONTACT

troche@rcsi.ie

+35318093000

References

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.

Reference Type: BACKGROUND

PMID: 34597010 (View on PubMed)

Sarfati B, Honart JF, Leymarie N, Rimareix F, Al Khashnam H, Kolb F. Robotic da Vinci Xi-assisted nipple-sparing mastectomy: First clinical report. Breast J. 2018 May;24(3):373-376. doi: 10.1111/tbj.12937. Epub 2017 Dec 18.

Reference Type: BACKGROUND

PMID: 29251382 (View on PubMed)

Other Identifiers

25/72

Identifier Type: -

Identifier Source: org_study_id