Application of VascuLens 2.0, A Mixed Reality System for Surgical Guidance During DIEP Flap Harvest: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Operative times
研究概览
简要总结
This study incorporates the use of the VascuLens system, which relies on a mixed reality headset and software system, during the pre-operative stage of DIEP flap surgery. VascuLens utilizes augmented reality (AR) technology to project vasculature images obtained from computed tomography angiography (CTA) onto the patient's body. These projections are then traced onto the patient, and the accuracy of the key vascular anatomical landmarks in the projected images is compared to the accuracy of the conventional surgical markings of the same anatomical landmarks against the actual location of the dissected blood vessels. Higher accuracy may lead to improved patient care, reduced operative time and reduced risk of complications.
详细描述
Background and Rationale:
Breast reconstruction surgery is a surgical procedure that can be done after a breast removal surgery ("mastectomy"). One of the more common surgical methods for reconstruction involves taking a section of tissue from the abdomen that includes skin, fat, and blood vessels and relocating it to form the breast mound. This specific surgical method uses a section of the abdomen called the Deep Inferior Epigastric Artery Perforator (DIEP) flap. In order to accurately identify the necessary blood vessels for this surgery, surgeons generally take CTA (computed tomography angiography, a type of medical imaging to visualize a patient's blood vessels and tissues) of the abdomen before surgery to map out and visualize the positions of all the blood vessels during surgery.
The VascuLens is a mixed reality system that projects anatomical information onto a patient. In this study, the Vasculens system will project anatomical information, derived from the computed tomography angiography (CTA) images taken before surgery, onto a patient's body just prior to surgery.
In turn, the relevant projected vascular anatomy will be drawn onto the patient with a permanent marker. This will allow surgeons to see where important blood vessels are throughout the entire surgery rather than visualizing them in their minds. Great care, and a significant amount of time in the 8-hour DIEP flap reconstruction surgery, is often dedicated to separating the perforator arteries of the deep inferior epigastric artery and vein surrounding the rectus abdominis muscle. The authors of this study have developed the Vasculens system because they believe it will reduce the time to dissect the perforator arteries. Our pilot work confirmed the feasibility of use of the Vasculens system to accurately project patient-specific segmented anatomy for a DIEP free flap surgery.
Purpose:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≥ 19 years old
- •Patients must be undergoing a DIEP flap surgery after mastectomy for breast cancer or risk reduction
- •Patient is already scheduled for a pre-operative CTA as part of routine standard of care.
- •Note: Non-English speaking participants will be given the option to have a translator.
排除标准
- •Patients who have had a prior DIEP flap, as they may not have standard vascular anatomy and the previous surgery may have resulted in scarring and fibrosis that would potentially interfere with the accuracy of the projected anatomical information.
- •Patients who have not had a pre-operative CTA because no imaging-based surgical guidance can be provided
- •Patients who are pregnant at the time of surgery
- •Patients who had a pre-operative CTA done before they were considered for this trial
研究组 & 干预措施
using vasculens
干预措施: vasculens and cta (Procedure)
not using vasculens
结局指标
主要结局
Operative times
时间窗: surgery time
次要结局
- Chart review of surgical complications(at 6 months)
研究者
Kathryn Isaac
Assistant Professor and Surgeon
University of British Columbia