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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
38
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
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Mean operative time
Mean operative time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction.
Time frame: 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.
Time frame: Up to 6 months after reconstruction
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.
Time frame: Up to 1 year after reconstruction
Donor site complications
Number of donor site complications will be reported
Time frame: 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.
Time frame: 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.
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Time frame: Up to 1 year after reconstruction