Breast Cancer Clinical Trial
Breast Reconstruction Following Breast Cancer in Very High Risk Patients
Summary
The purpose of this study is to:
Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs
Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications
Full Description
Primary Endpoint(s)
Define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort
Compare immediate and delayed reconstruction outcome metrics through retrospective review
Secondary Endpoint(s)
Evaluate Quality of life of patients at a higher risk for developing breast reconstruction surgical complications undergoing immediate versus delayed reconstruction.
Compare complications and reoperations between immediate versus delayed reconstruction.
Compare the hospital costs between immediate versus delayed reconstruction
Evaluate the effectiveness of risk reduction strategies
Eligibility Criteria
Inclusion Criteria:
Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy.
Subjects must be breast reconstruction candidates using implant based breast reconstruction.
Subjects must have a pre-operative risk >20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates
Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
Prior breast cancer surgical treatment
Prior breast reconstruction
Inability to provide written consent
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There is 1 Location for this study
Cleveland Ohio, 44195, United States
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