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This research study is designed to look at whether the routine use of shave margins (by taking extra tissue at the time of partial mastectomy surgery) will reduce the chances of having positive surgical margins requiring another surgical procedure, and whether this affects the long-term chances of getting cancer back in your breast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shave Margins | Experimental |
| |
| No shave margins | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shave margins | Procedure | Partial mastectomy with shave margins. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal surgical treatment | To determine whether routine shave margins in breast cancer patients undergoing partial mastectomy will result in more optimal surgical treatment of breast cancer patients, as defined by reduced positive margin rates | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmesis | To determine the effect of routine shave margins on cosmesis | 12 months |
| Operative time | To determine the effect of routine shave margins on the time in the operating suite. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anees Chagpar, M.D. | The Breast Center -- Smilow Cancer Hospital at Yale-New Haven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27192352 | Derived | Chagpar AB, Horowitz NR, Killelea BK, Tsangaris T, Longley P, Grizzle S, Loftus M, Li F, Butler M, Stavris K, Yao X, Harigopal M, Bossuyt V, Lannin DR, Pusztai L, Davidoff AJ, Gross CP. Economic Impact of Routine Cavity Margins Versus Standard Partial Mastectomy in Breast Cancer Patients: Results of a Randomized Controlled Trial. Ann Surg. 2017 Jan;265(1):39-44. doi: 10.1097/SLA.0000000000001799. | |
| 26028131 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| No Shave Margins |
| Procedure |
Partial mastectomy without shave margins. |
|
| 12 months |
| Volume of tissue resected | To determine the effect of routine shave margins on the volume of tissue resected. | 12 months |
| Derived |
| Chagpar AB, Killelea BK, Tsangaris TN, Butler M, Stavris K, Li F, Yao X, Bossuyt V, Harigopal M, Lannin DR, Pusztai L, Horowitz NR. A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer. N Engl J Med. 2015 Aug 6;373(6):503-10. doi: 10.1056/NEJMoa1504473. Epub 2015 May 30. |
| D017437 |
| Skin and Connective Tissue Diseases |