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Impact of Systematic Shaving on Margins

Impact of Systematic Shaving on Margins

Recruiting
18 years and older
Female
Phase N/A

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Overview

The objective of this clinical trial is to demonstrate the reduction of positive margins in the definitive pathology of patients undergoing breast-conserving surgery with the systematic shaving technique compared to conventional surgery, and the reduction of second interventions for margin enlargement.

Description

Patients with breast cancer who undergo breast-conserving surgery are randomized in the operating room after lumpectomy into 2 groups of 117 patients each: shaving/no-shaving (standard surgery).

Eligibility

Inclusion Criteria:

  1. Breast-conserving surgery.
  2. Imaging diagnosis as the only breast tumor focus according to mammography, breast ultrasound and/or nuclear magnetic resonance;
  3. Pathological diagnosis of carcinoma in situ or infiltrating
  4. Oncoplastic without associated flaps;

Exclusion Criteria:

  1. Male patients;
  2. Patients with a history of ipsilateral breast cancer.
  3. Oncoplastic that includes flaps
  4. Multifocality or multicentricity;
  5. Pregnant or lactating patient;
  6. Stage IV patients;
  7. Patients eligible for mastectomy;

Study details
    Margin
    Tumor-Free
    Breast Cancer
    Surgery

NCT05782686

Hospital Universitari de Bellvitge

25 January 2024

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