Accuracy of Deep Inferior Epigastric Artery Perforator Mapping - Color Doppler Ultrasound Versus CT Angiography: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The average deviations (Δ) in localization of perforators in each of the groups [cm]
研究概览
简要总结
The goal of this clinical trial is to compare the accuracy and contribution of Color Doppler Ultrasound (CDU) guided Deep Inferior Epigastric Artery (DIEA) perforator mapping with or without mapping using Computer Tomography angiography (CTA) in women over 18 years undergoing 2021 unilateral or bilateral breast reconstruction with an abdominal free flap.
Participants underwent scheduled reconstruction of one or both breasts with a free flap transferred from the lower abdomen. If there is a comparison group: Researchers compared interventional groups - examined using preoperative CTA of the abdominal wall supplemented with an examination of the perforators using CDU (active comparator group), and examined exclusively by using the CDU (experimental group), to see the comparison of the accuracy and contribution of CDU-guided DIEA perforator mapping with CTA mapping.
The hypothesis is that CDU examination alone is not inferior to CTA examination supplemented with parameters that CTA does not show (flow velocity, vessel diameters), by measuring these parameters with CDU.
The main questions it aims to answer are:
- To evaluate the comparison of the accuracy of surgeon-conducted CDU perforator mapping in defining the significant/dominant perforators and their exact location [XY coordinates] with the accuracy of CTA mapping.
- To compare the time duration of the CDU examination was measured.
- To measure the Fat Necrosis of the flap [3 months postoperative ]
- To measure the Flap Loss [1-week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op].
详细描述
A blinded, randomized, prospective clinical trial was performed involving women over 18 years undergoing 2021 unilateral or bilateral breast reconstruction with an abdominal free flap. The inclusion of the mapping of major perforators as a part of preoperative deep inferior epigastric perforator (DIEP) flap planning reduces the operating time and complication rate. According to recent meta-analyses computed tomographic angiography (CTA) brings the most advantages; however, only a few studies comprising colour Doppler ultrasonography (CDU) were included with several biases in addition. Especially, studies directly comparing CTA and CDU (surgeons conducted in one study only, in one case) are rare. Recently, CDU has seen significant advances in quality and imaging capabilities, and ultrasound devices are widely available.
Women were originally randomized 1:1 to the groups one of which will undergo only CDU perforator mapping (experimental group) and the other using CTA+CDU (active comparator group). Every patient included in the CTA+CDU group preoperatively underwent CT angiography of the abdominal wall. Based on the CTA examination XY coordinates of DIEA perforators with a vessel calibre of 1 mm were determined.
The velocity and vessel diameters of these perforators were additionally examined using a CDU device. Any additional perforators were marked, nor were CTA deducted XY coordinates of marked perforators changed, based on the CDU examination. The same sonography surgeon performed all CDU examinations.
All patients included in the CDU group were examined with the same CDU device by the same sonography surgeon as patients included in CTA + CDU group. During the examination, DIEA perforators were mapped and those with a vessel calibre of 1 mm were marked and XY coordinates deducted. Calibres and velocities of perforator vessels and the abdominal subcutaneous tissue thickness were measured.
In the CTA+CDU group, CDU was used only to determine the additional parameters necessary to define categories 1-3 (according to the number of perforators). Based on CDU, coordinates were not measured in the CTA+CDU group. The main aim of this clinical study is to compare the accuracy of perforator localization (coordinates) using CDU vs. CTA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged 18 to 65 years;
- •undergoing uni- or bilateral breast free flap reconstruction harvested from the lower abdomen;
- •signed informed consent to participate in the study.
排除标准
- •history of allergy to iodinated contrast material;
- •history of abdominoplasty;
- •Body Mass index > 35;
- •active oncological disease ;
- •Karnofsky Performance Status < 50;
- •change of the reconstructive method as a result of the preoperative mapping;
- •non-standard performed CTA examination.
结局指标
主要结局
The average deviations (Δ) in localization of perforators in each of the groups [cm]
时间窗: Through study completion, an average of 1 year
In CDU group ΔCDU calculated for each dissected perforator as the Euclidean distance between (before the surgery, using CDU) mapped XY coordinates and the reference XY coordinates measured during the surgery. XY\[0;0\]=umbilicus In CTA+CDU group ΔCTU (because XY coordinates in this group are deducted only based on CTA, CDU in this group is used only as an additional modality to help predict the dissection category A, B, C not to deduct XY coordinates) calculated for each dissected perforator as the Euclidean distance between (before the surgery, using CTA) mapped XY coordinates and the reference XY coordinates measured during the surgery. XY\[0;0\]=umbilicus
The success rate in estimating proper dissecting strategy [%]
时间窗: Through study completion, an average of 1 year
In what percentage of cases the finally dissected flap category (A, B, C) is the same as the category estimated before the surgery based on CDU or CTA+CDU mapping.
次要结局
- Flap Loss(1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op)
- The time duration of the CDU examination.(3 months post-operative)
- Fat Necrosis of the flap(3 months post-operative)