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临床试验/NCT06277687
NCT06277687招募中不适用

Exploratory Study on the Application of Virtual Augmented Reality Combined With Finder in Preoperative Anterolateral Thigh Flap Perforator Positioning

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Specificity

研究概览

简要总结

Oral and maxillofacial region is an important anatomical part of human body, responsible for chewing, swallowing, language, expression, breathing and other physiological functions. The tissue defects in this area not only seriously affect the physiological function, but also lead to facial deformity and aesthetic damage, affecting the quality of life of patients. The anterolateral thigh flap has become one of the main methods for defect repair due to its large tissue volume and high survival rate, and one of the key steps to ensure a high survival rate is the location of the perforator. How to find the perforator more accurately by improving the detection scheme or locating the perforator according to the anatomical structure, and guide the preparation and cutting of the flap, is the main direction of current research. This study intends to conduct a exploratory study on perforator localization of flap , and explore its effectiveness and accuracy through sensitivity and specificity.

In this study, a total of 24 patients with maxillofacial defects caused by tumors, trauma and other reasons requiring anterolateral femoral flap repair were included, and the perforator branch of femoral anterolateral flap was positioned preoperatively by Virtual augmented reality combined with perforator positioning device and color Doppler ultrasound. After the anterolateral thigh flap was prepared, the incision was closed in the donor area of the leg, and the flap was transplanted free to the maxillofacial defect area for repair. The sensitivity, specificity, positive predictive value, negative predictive value, distance difference and odds ratio of the two methods were calculated respectively, and the differences of each evaluation index between the two groups were compared, mainly to evaluate the sensitivity and specificity between the two groups.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with oral and maxillofacial defects caused by malignant tumors or trauma require anterior lateral femoral skin flap repair after surgery
  • There is no history of leg trauma and surgery is feasible
  • No clinically significant positive signs were found in physical examination
  • No chronic or current illnesses such as heart, liver, pancreas, spleen, kidney, digestive tract, respiratory, blood, nervous system, etc
  • No abnormalities found in electrocardiogram (ECG) and X-ray film
  • Hepatitis B surface antigen (HBSAg), anti hepatitis C antibody (anti HCV), anti human immunodeficiency virus antibody (anti HIV), and negative Treponema pallidum (TP)
  • No clinically significant abnormalities were found in vital signs, blood routine, urine routine, blood biochemistry, and blood pregnancy tests
  • The patient voluntarily participated in this study and signed an informed consent form

排除标准

  • Have a history of leg injury or surgery
  • Significant abnormalities in blood routine, heart, lung, liver, and kidney functions, insufficient compensatory function, or severe systemic diseases
  • Pregnant or lactating women, or those planning to conceive within six months
  • Individuals with a history of mental illness who cannot cooperate with the examination
  • Individuals with allergic constitution or known allergies to contrast agent ingredients
  • The patient or guardian refuses to sign a written consent form

研究组 & 干预措施

perforator localization

Experimental

Virtual Augmented Reality combined with Finder and Color Doppler Ultrasound were used to locate the perforating branch of the descending branch of the lateral circumflex femoral artery, and the position of the perforator was compared with real perforator respectively during the operation.

干预措施: Virtual Augmented Reality Combined With Finder (Diagnostic Test)

结局指标

主要结局

Specificity

时间窗: during the operation

The percentage of actual no perforations correctly judged as no perforations according to this research method (true negative rate) is calculated as follows: true negative number /(true negative perforations + false positive perforations) =TN/(TN+FP)

Sensitivity

时间窗: during the operation

The percentage of actual perforating branches that are correctly determined as the perforating branches according to this research method (true positive rate) is calculated as follows: number of true positive perforations /(number of true positive perforations + number of false negative perforations) =TP/(TP+FN)

次要结局

  • positive predictive value(during the operation)
  • negative predictive value(during the operation)
  • Youden Index(during the operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Song Fan, MD

Associate Professor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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