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

Plain Language Summary

Simplified for easier understanding

This study is examining whether routinely shaving additional tissue from the edges of a surgical site during breast-conserving surgery (lumpectomy) reduces the likelihood that cancer cells are found at the surgical margins — which can require additional surgery. The goal is to evaluate whether this practice improves surgical outcomes. **You may be eligible if:** - You are a woman undergoing breast-conserving surgery (lumpectomy) - Your breast imaging shows a single tumor focus only - You have been diagnosed with breast cancer (either in situ or invasive) confirmed by pathology - You are having a straightforward lumpectomy without tissue flap reconstruction **You may NOT be eligible if:** - You are male - You have a history of cancer in the same breast - Your surgery involves flap-based reconstruction - Your cancer appears in multiple separate areas of the breast (multifocal or multicentric) - You are pregnant or breastfeeding - Your cancer has spread to distant sites (stage IV) - You require a mastectomy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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