Avaliação da simetria facial após reconstrução facial por estereofotogrametria tridimensional (SymFACE)
Desenvolvimento, validação e aplicação clínica de método para avaliação quantitativa 3D da simetria facial após reconstrução facial utilizando estereofotogrametria 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Nicolas GRAILLON, MD
- Número de telefone: +33 04 91 43 6319
- E-mail: nicolas.graillon@ap-hm.fr
Locais de estudo
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Marseille, França, 13005
- Recrutamento
- Assistance Publique - Hôpitaux de Marseille
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Contato:
- Nicolas GRAILLON, MD
- Número de telefone: +33 04 91 43 63 19
- E-mail: nicolas.graillon@ap-hm.fr
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Investigador principal:
- Nicolas GRAILLON, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients who underwent facial reconstruction, returning for consultation 1 year to 5 years post-surgery.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Coeficiente de correlação entre a pontuação do desvio quadrático médio (RMSE) e a pontuação da avaliação do cirurgião
Prazo: Dia 1
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Dia 1
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Coeficiente de Correlação Intraclasse para avaliar a reprodutibilidade intraoperador
Prazo: Dia 1
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Dia 1
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Coeficiente de Correlação Intraclasse para avaliar a reprodutibilidade interoperador
Prazo: Dia 1
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Dia 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
- Diretor de estudo: CREMIEUX François, AP-HM
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RCAPHM23_0384
- ID RCB (Outro identificador: 2023-A02406-39)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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