Breast Reconstruction
Conditions
Brief summary
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.
Detailed description
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
Interventions
PROCEDURE3D medical models
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
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have histologically or cytologically confirmed breast caner undergoing delayed or immediate breast reconstruction. * Performance statusECOG Performance status ≤ 2 * Subjects must have normal organ and marrow function as defined below: * Hemoglobin ≥ 10.0 g/dl * Leukocytes ≥ 3,000/mcL * Absolute neutrophil count ≥ 1,500/mcL * Platelet count ≥ 100,000/mcL * Total bilirubin within normal institutional limits * AST (SGOT) ≤ 2.5 X institutional upper limit of normal * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal * Serum Creatinine within normal institutional limits * Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Subjects receiving any prior abdominoplasty or abdominal liposuction, or patient that plan on undergoing radiation therapy after reconstruction. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to IV contrast. * Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant or breastfeeding women are excluded from this study because IV contrast and CT scans have the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with breast cancer, breastfeeding should be discontinued. * Unsuitable donor site volume or vasculature based on pre-operative imaging or physical exam.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean operative time | Up to 6 months after reconstruction | Mean operative time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction. |
| Mean dissection time | Up to 6 months after reconstruction | Mean dissection time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aesthetic outcomes as measured by the Harris scale | Up to 1 year after reconstruction | Aesthetic outcomes as measured by the Harris scale, which ranges from 1-4, with higher scores indicating worse outcomes. |
| Donor site complications | Up to 1 year after reconstruction | Number of donor site complications will be reported |
| Incidence of fat necrosis as measured by a grading system | 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post reconstruction. | 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. |
| Patient satisfaction as measured by BREAST-Q scores | Up to 1 year after reconstruction | Patient satisfaction as measured by BREAST-Q scores which ranges from 4-16, with higher scores indicating more satisfaction with breasts. |
Countries
United States
Outcome results
None listed