Breast Reconstruction Following Breast Cancer in Very High Risk Patients
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 2/14/2019 |
| Start Date: | April 2019 |
| End Date: | July 2022 |
| Contact: | Risal Djohan, MD |
| Email: | djohanr@ccf.org |
| Phone: | 440-878-2500 |
Evaluating Breast Reconstruction Timing and Risk Reduction Strategies in Patients at a Higher Risk for Developing Breast Reconstruction Surgical Complications: A Prospective Randomized Study
The purpose of this study is to:
1. 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
2. Determine the efficacy of risk reduction strategies for breast reconstruction patients
with higher risk for surgical complications
1. 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
2. Determine the efficacy of risk reduction strategies for breast reconstruction patients
with higher risk for surgical complications
Primary Endpoint(s)
1. Define the optimal timing of reconstruction in patients at a higher risk for developing
breast reconstruction surgical complications through a randomized prospective cohort
2. Compare immediate and delayed reconstruction outcome metrics through retrospective
review
Secondary Endpoint(s)
1. Evaluate Quality of life of patients at a higher risk for developing breast
reconstruction surgical complications undergoing immediate versus delayed
reconstruction.
2. Compare complications and reoperations between immediate versus delayed reconstruction.
3. Compare the hospital costs between immediate versus delayed reconstruction
4. Evaluate the effectiveness of risk reduction strategies
1. Define the optimal timing of reconstruction in patients at a higher risk for developing
breast reconstruction surgical complications through a randomized prospective cohort
2. Compare immediate and delayed reconstruction outcome metrics through retrospective
review
Secondary Endpoint(s)
1. Evaluate Quality of life of patients at a higher risk for developing breast
reconstruction surgical complications undergoing immediate versus delayed
reconstruction.
2. Compare complications and reoperations between immediate versus delayed reconstruction.
3. Compare the hospital costs between immediate versus delayed reconstruction
4. Evaluate the effectiveness of risk reduction strategies
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
We found this trial at
1
site
10201 Carnegie Avenue
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Principal Investigator: Risal Djohan, MD
Phone: 440-878-2500
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