Trials / Unknown
UnknownNCT03105570
The Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 145 (estimated)
- Sponsor
- Peking University People's Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
To balance the oncological safety and cosmetic outcome is the basic principle of modern breast surgery. To preserve the nipple-areolar complex shows attractive cosmetic advantage but concerns regarding local recurrence make the oncological safety of nipple sparing mastectomy a controversial issue. Since the involvement of areolar pigmented skin by cancer is rare compared to that of nipple, we designed the current study to investigate the oncological safety and cosmetic outcome of Areola Sparing Mastectomy.
Detailed description
Primary breast cancer originated from areolae is rare. We hypothesized that nipple and areola are two separate anatomy tissue and have different oncological impact on the treatment of breast cancer. Areola Sparing Mastectomy (ASM) is a innovative procedure that involves of removal of nipple and preservation of areola the pigmented skin of which would improve the cosmetic outcome of mastectomy and lead to a illusion of congenital crater nipple in some patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Areola Sparing Mastectomy | A small circular incision would be made to separate nipple from breast and an additional incision directly extended from nipple or located at other part of breast such as infra-mammary fold and subaxillary area would be made to remove the total mammary parenchyma. Routine implant based or flap base reconstruction would be performed subsequentially. Nipple reconstruction is optional. |
Timeline
- Start date
- 2017-05-01
- Primary completion
- 2024-05-01
- Completion
- 2024-05-01
- First posted
- 2017-04-10
- Last updated
- 2022-10-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03105570. Inclusion in this directory is not an endorsement.