Nipple Sparing Mastectomy - Cosmetic Outcomes
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nipple Sparing Mastectomy Patients who undergo nipple sparing mastectomy with preservation of the nipple areolar complex. |
Procedure: Nipple Sparing Mastectomy
Skin sparing mastectomy with preservation of the nipple areolar complex
|
Outcome Measures
Primary Outcome Measures
- 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
- Complications [First Post Operative year]
- Local Recurrence [One year]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Richard L White, MD, Carolinas Healthcare
Study Documents (Full-Text)
None provided.More Information
Publications
- Banerjee A, Gupta S, Bhattacharya N. Preservation of nipple-areola complex in breast cancer--a clinicopathological assessment. J Plast Reconstr Aesthet Surg. 2008 Oct;61(10):1195-8. Epub 2007 Sep 27.
- Carlson GW, Losken A, Moore B, Thornton J, Elliott M, Bolitho G, Denson DD. Results of immediate breast reconstruction after skin-sparing mastectomy. Ann Plast Surg. 2001 Mar;46(3):222-8.
- Crowe JP Jr, Kim JA, Yetman R, Banbury J, Patrick RJ, Baynes D. Nipple-sparing mastectomy: technique and results of 54 procedures. Arch Surg. 2004 Feb;139(2):148-50.
- Crowe JP, Patrick RJ, Yetman RJ, Djohan R. Nipple-sparing mastectomy update: one hundred forty-nine procedures and clinical outcomes. Arch Surg. 2008 Nov;143(11):1106-10; discussion 1110. doi: 10.1001/archsurg.143.11.1106.
- Fitzal F. Can nipple-sparing mastectomy and immediate breast reconstruction with modified extended latissimus dorsi muscular flap improve the cosmetic and functional outcome of patients with breast cancer? World J Surg. 2008 Mar;32(3):499; author reply 500-1.
- Gerber B, Krause A, Reimer T, Müller H, Küchenmeister I, Makovitzky J, Kundt G, Friese K. Skin-sparing mastectomy with conservation of the nipple-areola complex and autologous reconstruction is an oncologically safe procedure. Ann Surg. 2003 Jul;238(1):120-7.
- Laronga C, Kemp B, Johnston D, Robb GL, Singletary SE. The incidence of occult nipple-areola complex involvement in breast cancer patients receiving a skin-sparing mastectomy. Ann Surg Oncol. 1999 Sep;6(6):609-13.
- Loewen MJ, Jennings JA, Sherman SR, Slaikeu J, Ebrom PA, Davis AT, Fitzgerald TL. Mammographic distance as a predictor of nipple-areola complex involvement in breast cancer. Am J Surg. 2008 Mar;195(3):391-4; discussion 394-5. doi: 10.1016/j.amjsurg.2007.12.020.
- Lowery JC, Wilkins EG, Kuzon WM, Davis JA. Evaluations of aesthetic results in breast reconstruction: an analysis of reliability. Ann Plast Surg. 1996 Jun;36(6):601-6; discussion 607.
- Sacchini V, Pinotti JA, Barros AC, Luini A, Pluchinotta A, Pinotti M, Boratto MG, Ricci MD, Ruiz CA, Nisida AC, Veronesi P, Petit J, Arnone P, Bassi F, Disa JJ, Garcia-Etienne CA, Borgen PI. Nipple-sparing mastectomy for breast cancer and risk reduction: oncologic or technical problem? J Am Coll Surg. 2006 Nov;203(5):704-14. Epub 2006 Sep 11.
- Stolier AJ, Sullivan SK, Dellacroce FJ. Technical considerations in nipple-sparing mastectomy: 82 consecutive cases without necrosis. Ann Surg Oncol. 2008 May;15(5):1341-7. doi: 10.1245/s10434-007-9753-5. Epub 2008 Feb 7.
- Vlajcic Z, Zic R, Stanec S, Lambasa S, Petrovecki M, Stanec Z. Nipple-areola complex preservation: predictive factors of neoplastic nipple-areola complex invasion. Ann Plast Surg. 2005 Sep;55(3):240-4.
- Wijayanayagam A, Kumar AS, Foster RD, Esserman LJ. Optimizing the total skin-sparing mastectomy. Arch Surg. 2008 Jan;143(1):38-45; discussion 45. doi: 10.1001/archsurg.143.1.38.
- LCI NAC-SSM