- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06534970
Valutazione della simmetria facciale dopo la ricostruzione facciale mediante stereofotogrammetria tridimensionale (SymFACE)
Sviluppo, validazione e applicazione clinica di un metodo per la valutazione quantitativa 3D della simmetria facciale dopo la ricostruzione facciale mediante stereofotogrammetria tridimensionale
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Nicolas GRAILLON, MD
- Numero di telefono: +33 04 91 43 6319
- Email: nicolas.graillon@ap-hm.fr
Luoghi di studio
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Marseille, Francia, 13005
- Reclutamento
- Assistance Publique - Hôpitaux de Marseille
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Contatto:
- Nicolas GRAILLON, MD
- Numero di telefono: +33 04 91 43 63 19
- Email: nicolas.graillon@ap-hm.fr
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Investigatore principale:
- Nicolas GRAILLON, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Patients who underwent facial reconstruction, returning for consultation 1 year to 5 years post-surgery.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Coefficiente di correlazione tra il punteggio di deviazione quadratica media (RMSE) e il punteggio di valutazione del chirurgo
Lasso di tempo: Giorno 1
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Giorno 1
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Coefficiente di correlazione intraclasse per valutare la riproducibilità intra-operatore
Lasso di tempo: Giorno 1
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Giorno 1
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Coefficiente di correlazione intraclasse per valutare la riproducibilità tra operatori
Lasso di tempo: Giorno 1
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Giorno 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
Investigatori
- Direttore dello studio: CREMIEUX François, AP-HM
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RCAPHM23_0384
- ID RCB (Altro identificatore: 2023-A02406-39)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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