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insufficient staff
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The purpose of this study is to:
Primary Endpoint(s)
Secondary Endpoint(s)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate breast reconstruction | Active Comparator | The surgical schedule will follow unaltered standard protocol for immediate reconstruction right after the patient's mastectomy. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and at different time points during the follow up. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs. |
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| Delayed breast reconstruction | Experimental | Patients will start the reconstruction process after cancer therapy has been completed. Patients will be directed to smoking cessation and weight loss resources such as the Bariatric Institute to most directly facilitate risk reduction goals. Risk scores will be assessed at a plastic surgery appointment every 3 months. Reconstruction will proceed after the cancer treatment has been completed, according to individual patient evaluation. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and after the final reconstruction surgery. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Breast Reconstruction | Procedure | Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery. Reconstruction will be attempted immediately after mastectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications | Proportion of patients preferring delayed reconstruction. | Until 1 year post breast reconstruction |
| Measure | Description | Time Frame |
|---|---|---|
| Major complications | defined as the ones that required reoperation (infection, capsular contracture, hematoma, seroma, skin flap and flap necrosis, etc). | Until 1 year post breast reconstruction |
| Minor complications |
| Measure | Description | Time Frame |
|---|---|---|
| Aesthetic evaluation | Aesthetic evaluation using postoperative photos one year after the first surgery, and after the final reconstruction surgery | Until 1 year post breast reconstruction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Risal Djohan, MD | Cleveland Clinic, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
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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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| Delayed Breast Reconstruction | Procedure | Risk reduction strategies on smoking, weight, and chronic disease control will be offered. The individual risk will be recalculated every three months. Delayed breast reconstruction will be offered when core cancer therapies (mastectomy, chemotherapy and radiation) are complete. Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery. |
|
| Breast-Q questionnaire | Other | Developed out of Memorial Sloan-Kettering Institute for Cancer Research, this questionnaire is designed to create a patient-reported outcome measure to provide quantifiable information about the impact and effectiveness of breast surgery. In this study it will be used for quality of life assessment |
|
defined as the ones that were office treated, not requiring a reoperation
| Until 1 year post breast reconstruction |
| Number of revision surgeries | defined as surgeries not related to complications, indicated for symmetrization, aesthetic improvement, nipple reconstruction, or skin paddle removal | Until 1 year post breast reconstruction |
| Hospital cost of the complete reconstruction treatment | Cost of reconstruction including the cost of complications | Until 1 year post breast reconstruction |
| Change in patient satisfaction | Patient satisfaction using the pre-operative Breast-Q questionnaire to define the baseline compared to score on Breast-Q questionnaire during follow-up | Until 1 year post breast reconstruction |
| D017437 |
| Skin and Connective Tissue Diseases |