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Completed

NCT Number: NCT04640454

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

28 year–68 year

Sex eligibility

Female

Study type

Observational

Primary location

Alexandria faculty of medicine

Alexandria, 21500, Egypt

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nipple sparing mastectomy

Procedure

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.

Primary outcomes

  1. patients complications after nipple sparing mastectomy

    Time frame: 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 outcomes

  1. Aesthetic results assessed by Tzafetta et al scoring system

    Time frame: 2017-2019

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 23, 2020
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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