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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shaving | Experimental | 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. |
|
| No Shaving | Active Comparator | Standard lumpectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Margin shaving | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| amparo garcia-tejedor, MDPhD | Contact | 932607695 | agarciat@bellvitgehospital.cat |
| Name | Affiliation | Role |
|---|---|---|
| Amparo Garcia Tejedor, MDPhD | Hospital de Bellvitge. Instituto de Investigación Biomédica de Bellvitge (IDIBELL) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
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| ID | Term |
|---|---|
| D000072662 | Margins of Excision |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Randomized clinical trial
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Randomization will be performed by another investigator outside the operating room after lumpectomy.
|
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |