Impact of Systematic Shaving on Margins
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital Universitari de Bellvitge
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Male patients;
Patients with a history of ipsilateral breast cancer.
Oncoplastic that includes flaps
Multifocality or multicentricity;
Trial design
Design model
Parallel
Treatments tested in this trial
Margin shaving
Procedure/SurgeryIn 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.
Treatment groups
234 Participants
are divided into 2 treatment groupsGroup A: ShavingExperimental treatment 1 intervention
Group B: No ShavingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Margin 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 surgery2
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 surgerySecondary outcomes
1
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 surgerySponsors and contacts
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Source ClinicalTrials.gov