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| Name | Class |
|---|---|
| Royal College of Surgeons, Ireland | OTHER |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-port robotic nipple-sparing mastectomy with immediately implant based reconstruction. | Experimental | Intervention |
|
| Standard open nipple sparing mastectomy with immediate implant-based reconstruction. | Active Comparator | Standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Procedure | Single-port robotic nipple-sparing mastectomy with immediately implant based reconstruction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measures |
| 1 year |
| Primary Outcome Measure | The primary endpoint of this study is the difference Breast Q scores at 12 months. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trudi Roche Nelson, ANP RGN MSC | Contact | +35318093000 | troche@rcsi.ie |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34597010 | Background | 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. | |
| 29251382 |
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Protocol and anonymous study data will be shared through peer reviewed publication
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| Standard open nipple sparing mastectomy with immediate implant-based reconstruction | Procedure | Standard open nipple sparing mastectomy with immediate implant-based reconstruction |
|
| Background |
| 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. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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