Margin 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.
Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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;
Primary outcome measure(s)
Margin involvement — 3 weeks after each surgery To compare the number of cases with affected margins in the definitive pathological anatomy, of the cases with intraoperative systematic shaving versus the group of no shaving
Re-interventions — 3 weeks after each surgery Demonstrate the reduction of second surgeries to widen affected margins in breast conserving surgery with the shaving technique
Trial sites (1)
Facility
City
Region
Status
Hospital de Bellvitge
L'Hospitalet de Llobregat
Barcelona
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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