Clinical trial · Interventional
Nipple Sparing Mastectomy - Cosmetic Outcomes
Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy
NCT01002014CI-TRIAL-00057968completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Reconstruction | — | UNRESOLVED | — |
| Cosmesis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nipple Sparing Mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nipple Sparing Mastectomy
- description
- Patients who undergo nipple sparing mastectomy with preservation of the nipple areolar complex.
- interventionNames
- Procedure: Nipple Sparing Mastectomy
Primary outcomes (4)
- measure
- Cosmetic Appearance
- timeFrame
- First Post Operative year
- measure
- Patient Satisfaction
- timeFrame
- First Post Operative Year
- measure
- Presence of tumor in nipple areolar complex frozen section
- timeFrame
- Duration of Study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDVlajcic 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. doi: 10.1097/01.sap.0000171680.49971.85. PMID 16106159
- BACKGROUNDCrowe 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. PMID 19015470
- BACKGROUNDCrowe 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. doi: 10.1001/archsurg.139.2.148. PMID 14769571
- BACKGROUNDSacchini 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. doi: 10.1016/j.jamcollsurg.2006.07.015. Epub 2006 Sep 11. PMID 17084333
- BACKGROUNDStolier 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. PMID 18256883
- BACKGROUNDWijayanayagam 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. PMID 18209151
- BACKGROUNDBanerjee 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. doi: 10.1016/j.bjps.2007.08.005. Epub 2007 Sep 27.