Intraoperative Stereotactic Image-guided Navigation of Perforators for DIEP Flap Breast Reconstruction.
I. To analyze the accuracy of preoperative CT angiography in determining the location of
perforator vessels. Through the use of an intraoperative navigation system, we will
objectively locate perforators during surgery and compare the results to the preoperative
imaging assessment of the flap's vascular anatomy.
II. To determine whether the preoperative CT angiogram allows the microsurgeon to correctly
identify the perforators that are ultimately used as the pedicle for the flap.
Patients undergo deep inferior epigastric perforator (DIEP) flap breast reconstruction using
the StealthStation navigation system.
After completion of study treatment, patients are followed up at 1-2 weeks and 1 month, then
every 3 months for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images
Up to 2 years
Ergun Kocak, MD
Ohio State University
United States: Institutional Review Board
|Ohio State University Medical Center||Columbus, Ohio 43210|