Impact of Systematic Shaving on Margins

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Margin, Tumor-Free, Breast Cancer, Surgery

Intervention / Treatment
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* Procedure: Margin shaving


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shaving<br>Subsequent to lumpectomy, a circumferential enlargement of all lumpectomy margins, including lateral, medial, superior, inferior, anterior, and posterior, approximately 5-10mm thick, will be resected. | Procedure: Margin shaving<br>* 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.<br>|
| Active Comparator: No Shaving<br>Standard lumpectomy | Procedure: Margin shaving<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 3 weeks after each surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shaving versus intraoperative pathological study | Assess the possibility of replacing the intraoperative study of the margins with systematic shaving | 3 weeks after each surgery |