Clinical trial · Observational
Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer
- 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)
Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is a form of mastectomy that achieves optimal disease control and facilitates reconstruction. The study aimed to assess the oncological safety and aesthetic outcomes of nipple-sparing mastectomy and immediate breast reconstruction. 35 female patients with breast cancer were included in the study. The investigators categorized the incisions into radial, inframammary, and periareolar incisions with planned reconstruction types; direct to implant (DTI), transversus rectus abdominis myocutaneous (TRAM) flap, latissimus dorsi myocutaneous (LD) flap, or LD with implant.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nipple sparing mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- patients complications after nipple sparing mastectomy
- timeFrame
- 2017-2019
- description
- Complete general examination, local examination of the skin, nipple and areola were done to determine whether the patients suffered from any complaints
Secondary outcomes (1)
- measure
- Aesthetic results assessed by Tzafetta et al scoring system
- timeFrame
- 2017-2019
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 28 Years
- Maximum age
- 68 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of ductal in situ carcinoma or infiltrating ductal carcinoma with a tumor diameter up to 3 cm * Distance of the tumor from the nipple ≥ 2 cm * Cancer or microcalcifications not localized in the central field. * No blood secretions or other (nipple-areola complex) NAC disturbances * Absence of skin involvement * Indication to mastectomy for multifocal or diffuse microcalcifications * Negative intraoperative assessment of NAC-bottom Exclusion Criteria: * Tumor or microcalcifications localized in the central quadrant or in the retroareolar region * Blood secretions or other NAC alterations * Positive intraoperative assessment of NAC-bottom * Inflammatory carcinoma * Paget's disease of the nipple
References
Publications (0)
Data not yet available