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

A

Alexandria University

Status

Completed

Conditions

Breast Cancer

Treatments

Procedure: nipple sparing mastectomy

Study type

Observational

Funder types

Other

Identifiers

NCT04640454
13-27-10

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

Female

Ages

28 to 68 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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