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The purpose of this study is to determine if 3D modeling and Virtual Planning Surgery can improve the clinical outcome with patient who have a mastectomy requiring breast reconstruction.
Primary objective: Using 3D medical models of the abdomen, a virtual plan will assist reconstruction to clearly define and 3D model the normal and aberrant vascular anatomy of the donor site in order to decrease dissection time and secondary perioperative complications including fat necrosis and donor site complications.
Secondary objective: To propose incision lines to match the corresponding volumetric analysis of the transposed tissue in order to facilitate the creation of a patient specific tailored flap, which will improve the aesthetic outcomes.
This is a single-armed, prospective study to determine the feasibility of using 3-D virtual planning and medical modeling in breast cancer patients undergoing breast reconstruction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-D virtual planning and medical modeling of breast | Experimental | 3-D virtual planning and medical modeling in breast cancer patients undergoing breast reconstruction.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D medical models | Procedure | Using 3D medical models of the abdomen, a virtual plan will assist reconstruction to clearly define and 3D model the normal and aberrant vascular anatomy of the donor site in order to decrease both operative time and dissection time. This will also allow for the proposal of incision lines to match the corresponding volumetric analysis of the transposed tissue in order to facilitate the creation of a patient specific tailored flap, which will improve the aesthetic outcomes, decrease donor site complications and improve patient satisfaction |
| Measure | Description | Time Frame |
|---|---|---|
| Mean operative time | Mean operative time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction. | Up to 6 months after reconstruction |
| Mean dissection time | Mean dissection time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction. | Up to 6 months after reconstruction |
| Measure | Description | Time Frame |
|---|---|---|
| Aesthetic outcomes as measured by the Harris scale | Aesthetic outcomes as measured by the Harris scale, which ranges from 1-4, with higher scores indicating worse outcomes. | Up to 1 year after reconstruction |
| Donor site complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amir Ghaznavi | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
All IPD that underlie results in publication
at the conclusion of study and for 5 years
data requestor will need to sign a data access agreement.
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Number of donor site complications will be reported
| Up to 1 year after reconstruction |
| Incidence of fat necrosis as measured by a grading system | Incidence of fat necrosis will be measured in the postoperative period using a classification system. Grade I necrosis will be defined as minimal requiring no surgical intervention; Grade II necrosis will be minor with some aesthetic defect requiring primary excision and closure; Grade III necrosis will be defined as requiring secondary procedures after excision to achieve satisfactory cosmesis; Grade IV necrosis will involve a necrosectomy requiring a either a completely new flap or at least a second flap to address such problems; Grade V necrosis will be defined as complete flap failure 5. Higher grade of fat necrosis is worse. | 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post reconstruction. |
| Patient satisfaction as measured by BREAST-Q scores | Patient satisfaction as measured by BREAST-Q scores which ranges from 4-16, with higher scores indicating more satisfaction with breasts. | Up to 1 year after reconstruction |