Évaluation de la symétrie faciale après reconstruction faciale par stéréophotogrammétrie tridimensionnelle (SymFACE)
Développement, validation et application clinique d'une méthode d'évaluation quantitative 3D de la symétrie faciale après reconstruction faciale à l'aide de la stéréophotogrammétrie tridimensionnelle
Facial reconstruction follows removal of a malignant or benign tumor of the oral cavity or face, complex facial trauma, or resection of osteonecrosis of the jaws. It's a challenge that aims to restore not only the functions of the face, but also its aesthetics, which is just as crucial. A poor aesthetic result after facial reconstruction has a serious impact on patient's lives. To develop more personalized surgery, and to anticipate and correct poor results in the future, it is essential to better understand the factors associated with poor aesthetic results in this type of surgery, as well as their impact on the patient's life.
This means correctly assessing the aesthetic outcome of this surgery. Today, however, aesthetic evaluation criteria remain inadequate. A number of criteria are involved in facial attractiveness, and facial symmetry is a key factor. It is generally accepted that severe facial asymmetries considerably diminish facial attractiveness. Currently, aesthetic evaluation criteria (particularly symmetry) are based primarily on the subjective perception of the surgeon or patient. However, there is a need to be able to measure facial symmetry objectively.
Methods for assessing symmetry rely on the placement of anatomical landmarks and the calculation of Euclidean distance, which involves locating homologous landmarks on each side of the face and comparing the length ratios of all possible lines connecting the landmarks on each side. However, these techniques are based on measurements often on two-dimensional (2D) photographs and do not take into account the three-dimensional nature of the face. Methods for three-dimensional analysis of facial symmetry have been developed based on three-dimensional CT reconstructions. However, this technique implies the use of an irradiating imaging technique, not systematically indicated at a distance from surgery.
This study aims to validate a method for analyzing facial symmetry using three-dimensional stereophotogrammetry, to identify risk factors for facial asymmetry in patients who have undergone facial reconstruction, and to assess the impact of facial asymmetry on patients' quality of life.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nicolas GRAILLON, MD
- Numéro de téléphone: +33 04 91 43 6319
- E-mail: nicolas.graillon@ap-hm.fr
Lieux d'étude
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Marseille, France, 13005
- Recrutement
- Assistance Publique - Hôpitaux de Marseille
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Contact:
- Nicolas GRAILLON, MD
- Numéro de téléphone: +33 04 91 43 63 19
- E-mail: nicolas.graillon@ap-hm.fr
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Chercheur principal:
- Nicolas GRAILLON, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Patients who underwent facial reconstruction, returning for consultation 1 year to 5 years post-surgery.
La description
Inclusion Criteria:
- Male or female, 18 years of age or older,
- Patient having given non-opposition for participation in this study,
- Reconstruction of the lower or middle third of the face by pedicled flap or microanastomosed free flap following excision of a benign or malignant tumor of the oral cavity or face, osteonecrosis of the jaws, loss of facial traumatic substance,
- Surgery and routine follow-up performed in the 3 departments (maxillofacial surgery, ENT, plastic and reconstructive surgery) of the PROMOD cluster at Marseille's CHU Conception
Exclusion Criteria:
- History of reconstruction of the lower or middle third of the face other than that being evaluated at one year for this study,
- Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship, patients deprived of their liberty, pregnant or breast-feeding women),
- Persons who cannot read and understand the French language well enough to be able to give their non-opposition to participating in the research.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Facial reconstruction patients
Reconstruction of the lower or middle third of the face using a pedicled flap or microanastomosed free flap following excision of a benign or malignant tumor of the oral cavity or face, osteonecrosis of the jaws, or traumatic loss of facial substance |
Three stereoscopic photographs
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Coefficient de corrélation entre le score d'écart quadratique moyen (RMSE) et le score d'évaluation du chirurgien
Délai: Jour 1
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Jour 1
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Coefficient de corrélation intraclasse pour évaluer la reproductibilité intra-opérateur
Délai: Jour 1
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Jour 1
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Coefficient de corrélation intraclasse pour évaluer la reproductibilité inter-opérateurs
Délai: Jour 1
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Jour 1
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Description of the Root Mean Square Error (RMSE) and associated parameters from the FACE sculptor® Vectra Analysis Module (minimum, maximum, median and mean) to characterize measurement distribution and detect potential anomalies
Délai: Day 1
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Day 1
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Demographic factors associated with objective facial asymmetry one year to five years after facial reconstruction surgery
Délai: Day 1
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Day 1
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Clinical factors associated with objective facial asymmetry one year to five years after facial reconstruction surgery
Délai: Day 1
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Day 1
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Therapeutic factors associated with objective facial asymmetry one year to five years after facial reconstruction surgery
Délai: Day 1
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Day 1
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Relationship between objective measurement of facial asymmetry and the patient's subjective assessment of perception (satisfaction and body image)
Délai: Day 1
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The patient perception score is assessed by a scale constructed by the investigative team. |
Day 1
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Relationship between objective measurement of facial asymmetry and the patient's quality of life
Délai: Day 1
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The patient quality of life score is assessed by the French-validated SF-36 quality of life scale for general health inquiry" (36 items). |
Day 1
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Relationship between objective measurement of facial asymmetry and patient self-esteem
Délai: Day 1
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The patient self-esteem score is assessed by the French-validated Rosenberg self-esteem scale (10 items). |
Day 1
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Directeur d'études: CREMIEUX François, AP-HM
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RCAPHM23_0384
- ID RCB (Autre identifiant: 2023-A02406-39)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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