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

NCT ID: NCT06277687

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2024-07-15

Brief Summary

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.

Conditions

Blood Vessel Perforation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

perforator localization

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.

Group Type: EXPERIMENTAL

Virtual Augmented Reality Combined With Finder

Intervention Type: DIAGNOSTIC_TEST

After CT examination, the computer carried out three-dimensional reconstruction of blood vessels, and input the CTA data into Cinematic Anatomy reconstruction software to analyze blood vessels, Muscles and other tissues are reconstructed in three dimensions. Before the operation, the Finder is used to restore the position of the thigh during CTA examination. The Hololens is used to match the reconstructed three-dimensional image with the perforator locator and the thigh. Before the operation, the pedicles of the descending branches of the lateral arteries and the perforating vessels are marked on the skin of the thigh to achieve the positioning and marking of the perforating branches.

Interventions

Virtual Augmented Reality Combined With Finder

After CT examination, the computer carried out three-dimensional reconstruction of blood vessels, and input the CTA data into Cinematic Anatomy reconstruction software to analyze blood vessels, Muscles and other tissues are reconstructed in three dimensions. Before the operation, the Finder is used to restore the position of the thigh during CTA examination. The Hololens is used to match the reconstructed three-dimensional image with the perforator locator and the thigh. Before the operation, the pedicles of the descending branches of the lateral arteries and the perforating vessels are marked on the skin of the thigh to achieve the positioning and marking of the perforating branches.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Color Doppler ultrasound

Eligibility Criteria

Inclusion Criteria

1. All patients with oral and maxillofacial defects caused by malignant tumors or trauma require anterior lateral femoral skin flap repair after surgery

2. There is no history of leg trauma and surgery is feasible

3. No clinically significant positive signs were found in physical examination

4. No chronic or current illnesses such as heart, liver, pancreas, spleen, kidney, digestive tract, respiratory, blood, nervous system, etc

5. No abnormalities found in electrocardiogram (ECG) and X-ray film

6. Hepatitis B surface antigen (HBSAg), anti hepatitis C antibody (anti HCV), anti human immunodeficiency virus antibody (anti HIV), and negative Treponema pallidum (TP)

7. No clinically significant abnormalities were found in vital signs, blood routine, urine routine, blood biochemistry, and blood pregnancy tests

8. The patient voluntarily participated in this study and signed an informed consent form

Exclusion Criteria

1. Have a history of leg injury or surgery

2. Significant abnormalities in blood routine, heart, lung, liver, and kidney functions, insufficient compensatory function, or severe systemic diseases

3. Pregnant or lactating women, or those planning to conceive within six months

4. Individuals with a history of mental illness who cannot cooperate with the examination

5. Individuals with allergic constitution or known allergies to contrast agent ingredients

6. The patient or guardian refuses to sign a written consent form

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Song Fan, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Song Fan

Role: STUDY_CHAIR

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

Locations

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

Guanzhou, Guangdong, China

Countries

China

Other Identifiers

SYSKY-2024-023-02

Identifier Type: -

Identifier Source: org_study_id