Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04640454

Enrollment

Registered

2020-11-23

Start date

2017-01-01

Completion date

2019-01-01

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, mastectomy, breast reconstruction

Brief summary

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.

Interventions

PROCEDUREnipple sparing mastectomy

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

28 Years to 68 Years

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

Design outcomes

Primary

Measure	Time frame	Description
patients complications after nipple sparing mastectomy	2017-2019	Complete general examination, local examination of the skin, nipple and areola were done to determine whether the patients suffered from any complaints

Secondary

Measure	Time frame
Aesthetic results assessed by Tzafetta et al scoring system	2017-2019

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026