A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients
|ClinicalTrials.gov Identifier: NCT01452399|
Recruitment Status : Active, not recruiting
First Posted : October 14, 2011
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Shave margins Procedure: No Shave Margins||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||251 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||October 2020|
|Experimental: Shave Margins||
Procedure: Shave margins
Partial mastectomy with shave margins.
|Active Comparator: No shave margins||
Procedure: No Shave Margins
Partial mastectomy without shave margins.
- Optimal surgical treatment [ Time Frame: 12 months ]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
- Cosmesis [ Time Frame: 12 months ]To determine the effect of routine shave margins on cosmesis
- Operative time [ Time Frame: 12 months ]To determine the effect of routine shave margins on the time in the operating suite.
- Volume of tissue resected [ Time Frame: 12 months ]To determine the effect of routine shave margins on the volume of tissue resected.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452399
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Anees Chagpar, M.D.||The Breast Center -- Smilow Cancer Hospital at Yale-New Haven|