Nipple Sparing Mastectomy - Cosmetic Outcomes

Study Overview
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Brief Summary
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The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex.

Detailed Description
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The outcomes will be observed in patients with both known cancer diagnosis and in those with indications for prophylactic mastectomy. The cosmetic appearance and complications will be followed through several post operative visits throughout the duration of the study. This study is conducted in conjunction with the plastic and reconstructive surgeons who will be performing the breast reconstruction procedures. Patient satisfaction will be measured via survey format. In addition, local recurrence rates will be compared to patients undergoing traditional mastectomy.

Official Title
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Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy

Conditions
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Breast Cancer, Breast Reconstruction, Cosmesis

Intervention / Treatment
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* Procedure: Nipple Sparing Mastectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring mastectomy for cancer and/or prophylaxis Age greater than or equal to 18 at time of surgery BMI less than or equal to 35 If mastectomy is indicated for removal of breast cancer, tumor is clinically T1 or T2 Exclusion Criteria: Currently smoking Prior radiation to the affected breast Systemic lupus erythematosus Central tumor location and/or tumor within 2 cm of NAC Paget's disease of the nipple Clinical evidence of tumor involvement in the nipple Clinical evidence of axillary nodal tumor involvement Lymphovascular invasion of the tumor on core biopsy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nipple Sparing Mastectomy<br>Patients who undergo nipple sparing mastectomy with preservation of the nipple areolar complex. | Procedure: Nipple Sparing Mastectomy<br>* Skin sparing mastectomy with preservation of the nipple areolar complex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic Appearance |  | First Post Operative year | 
| Patient Satisfaction |  | First Post Operative Year | 
| Presence of tumor in nipple areolar complex frozen section |  | Duration of Study | 
| Presence of tumor in nipple areolar complex permanent histology |  | Duration of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  | First Post Operative year | 
| Local Recurrence |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Skin Sparing Mastectomy, Breast Cancer Prophylaxis, Nipple Sparing Mastectomy, Nipple Areolar Complex, Mastectomy, Breast Reconstruction, Local recurrence following nipple sparing mastectomy, Cosmetic outcomes following nipple sparing mastectomy, Complications following nipple sparing mastectomy