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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
234
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.
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGMargin involvement
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
Time frame: 3 weeks after each surgery
Re-interventions
Demonstrate the reduction of second surgeries to widen affected margins in breast conserving surgery with the shaving technique
Time frame: 3 weeks after each surgery
Shaving versus intraoperative pathological study
Assess the possibility of replacing the intraoperative study of the margins with systematic shaving
Time frame: 3 weeks after each surgery
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