NCT03949491

Free Flap Breast Reconstruction Using Virtual Surgical Planning and 3-D Modeling

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Reconstruction

Interventions

Type	Name	Description
PROCEDURE	3D 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

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2019-05-14
• Last updated: 2024-02-07

Locations

1 site across 1 country: United States