RecruitingNot ApplicableNCT05782686

Impact of Systematic Shaving on Margins

Reduction of Affected Margins in Conservative Surgery for Breast Cancer: Impact of Systematic Shaving in the Operating Room


Sponsor

Hospital Universitari de Bellvitge

Enrollment

234 participants

Start Date

Oct 7, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria7

  • Male patients;
  • Patients with a history of ipsilateral breast cancer.
  • Oncoplastic that includes flaps
  • Multifocality or multicentricity;
  • Pregnant or lactating patient;
  • Stage IV patients;
  • Patients eligible for mastectomy;

Interventions

PROCEDUREMargin shaving

In both cohorts, an intraoperative study of the margins will be carried out, and enlargement of those margins that are affected will be carried out as indicated by the pathologist. Subsequently, shaving is performed in case of being randomized to the study group or surgery is completed in the control group.


Locations(1)

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

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NCT05782686


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