Clinical trial · Interventional
The Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study
- 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)
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.
Conditions
Conditions (1)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Areola Sparing Mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Areola sparing mastectomy.
- description
- Eligible patients undergo areola sparing mastectomy.
- interventionNames
- Procedure: Areola Sparing Mastectomy
Primary outcomes (1)
- measure
- Recurrence of areolar area
- timeFrame
- Five years after initial surgery
- description
- The frequency of histologically confirmed recurrence on the preserved pigmented areolar area.
Secondary outcomes (3)
- measure
- Cosmetic effect of reconstructed breast
- timeFrame
- 2-4 weeks after surgery; 2 years and 5 years after surgery.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive or in situ breast cancer. * cTis-2N0-1M0. * Indicated for total mastectomy and desire immediate breast reconstruction. Exclusion Criteria: * cT3-4 or cN2-N3 breast cancer. * Retraction of nipple or areola. * Involvement of subcutaneous layer by cancer on ultrasound or MRI.
References
Publications (0)
Data not yet available