Vurdering av ansiktssymmetri etter ansiktsrekonstruksjon ved bruk av tredimensjonal stereofotogrammetri (SymFACE)
Utvikling, validering og klinisk anvendelse av en metode for kvantitativ 3D-vurdering av ansiktssymmetri etter ansiktsrekonstruksjon ved bruk av tredimensjonal stereofotogrammetri
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Nicolas GRAILLON, MD
- Telefonnummer: +33 04 91 43 6319
- E-post: nicolas.graillon@ap-hm.fr
Studiesteder
-
-
-
Marseille, Frankrike, 13005
- Rekruttering
- Assistance Publique - Hôpitaux de Marseille
-
Ta kontakt med:
- Nicolas GRAILLON, MD
- Telefonnummer: +33 04 91 43 63 19
- E-post: nicolas.graillon@ap-hm.fr
-
Hovedetterforsker:
- Nicolas GRAILLON, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Patients who underwent facial reconstruction, returning for consultation 1 year to 5 years post-surgery.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Korrelasjonskoeffisient mellom root mean square deviation (RMSE) score og kirurgens vurderingsscore
Tidsramme: Dag 1
|
Dag 1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intraklasse korrelasjonskoeffisient for å vurdere intra-operator reproduserbarhet
Tidsramme: Dag 1
|
Dag 1
|
|
|
Intraklasse-korrelasjonskoeffisient for å vurdere inter-operatør-reproduserbarhet
Tidsramme: Dag 1
|
Dag 1
|
|
|
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
Tidsramme: Day 1
|
Day 1
|
|
|
Demographic factors associated with objective facial asymmetry one year to five years after facial reconstruction surgery
Tidsramme: Day 1
|
Day 1
|
|
|
Clinical factors associated with objective facial asymmetry one year to five years after facial reconstruction surgery
Tidsramme: Day 1
|
Day 1
|
|
|
Therapeutic factors associated with objective facial asymmetry one year to five years after facial reconstruction surgery
Tidsramme: Day 1
|
Day 1
|
|
|
Relationship between objective measurement of facial asymmetry and the patient's subjective assessment of perception (satisfaction and body image)
Tidsramme: Day 1
|
The patient perception score is assessed by a scale constructed by the investigative team. |
Day 1
|
|
Relationship between objective measurement of facial asymmetry and the patient's quality of life
Tidsramme: Day 1
|
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
|
|
Relationship between objective measurement of facial asymmetry and patient self-esteem
Tidsramme: Day 1
|
The patient self-esteem score is assessed by the French-validated Rosenberg self-esteem scale (10 items). |
Day 1
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studieleder: CREMIEUX François, AP-HM
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RCAPHM23_0384
- ID RCB (Annen identifikator: 2023-A02406-39)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .