Intraoperative Stereotactic Image-guided Navigation of Perforators for DIEP Flap Breast Reconstruction.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Whether the preoperative CT angiography allowed the surgeon to accurately predict the perforator vessels that were actually used in the final flap design and transfer
研究概览
简要总结
Many hospitals, including the Ohio State University Medical Center, will take pictures of the blood vessels in a patient's abdomen before they decide to perform a breast reconstruction using the patient's own tissue. These pictures are called computed tomography (CT) angiograms and are like a map of each patient's anatomy. However, no study has been reported that determined how accurate these pictures are at showing the surgeon where all of the blood vessels were located. This study will try to determine if these pictures are missing any blood vessels that are found during surgery and if the pictures show the correct location of the vessels
详细描述
PRIMARY OBJECTIVES:
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.
OUTLINE:
Patients undergo deep inferior epigastric perforator (DIEP) flap breast reconstruction using the StealthStation navigation system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed breast carcinoma or breast carcinoma in situ desiring unilateral or bilateral deep inferior epigastric perforator (DIEP) flap breast reconstruction
- •Patients must be candidates for elective surgery, without clinically significant cardiac or pulmonary disease (New York Heart Association [NYHA] class III/IV), without infection requiring antibiotics, and without serious illness requiring the use of steroids
- •Patients must have normal kidney function and no allergy to intravenous (IV) dye
排除标准
- •Patients with previous abdominal donor site flaps will be excluded along with patients with previous extensive surgery to the anterior abdomen
- •Patients with a weight of over 300 pounds or a body size not supported by the CT scanner will be excluded
- •Patients who are expected to undergo postoperative radiation therapy will be excluded
结局指标
主要结局
Whether the preoperative CT angiography allowed the surgeon to accurately predict the perforator vessels that were actually used in the final flap design and transfer
时间窗: Up to 2 years
The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images
时间窗: Up to 2 years
次要结局
- Position of the vessels on the imaging correlate to actual location on the abdominal wall for those perforator vessels that are identified both on preoperative review of the images and located during flap dissection(Up to 2 years)