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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06534970
Evaluación de la simetría facial después de la reconstrucción facial mediante estereofotogrametría tridimensional (SymFACE)
Desarrollo, validación y aplicación clínica de un método para la evaluación cuantitativa 3D de la simetría facial después de la reconstrucción facial mediante estereofotogrametría tridimensional
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nicolas GRAILLON, MD
- Número de teléfono: +33 04 91 43 6319
- Correo electrónico: nicolas.graillon@ap-hm.fr
Ubicaciones de estudio
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Marseille, Francia, 13005
- Reclutamiento
- Assistance Publique - Hôpitaux de Marseille
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Contacto:
- Nicolas GRAILLON, MD
- Número de teléfono: +33 04 91 43 63 19
- Correo electrónico: nicolas.graillon@ap-hm.fr
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Investigador principal:
- Nicolas GRAILLON, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients who underwent facial reconstruction, returning for consultation 1 year to 5 years post-surgery.
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Coeficiente de correlación entre la puntuación de la desviación cuadrática media (RMSE) y la puntuación de evaluación del cirujano
Periodo de tiempo: Día 1
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Día 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Coeficiente de correlación intraclase para evaluar la reproducibilidad intraoperador
Periodo de tiempo: Día 1
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Día 1
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Coeficiente de correlación intraclase para evaluar la reproducibilidad entre operadores
Periodo de tiempo: Día 1
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Día 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: CREMIEUX François, AP-HM
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RCAPHM23_0384
- ID RCB (Otro identificador: 2023-A02406-39)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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