Functional and Aesthetic Comparison of Surgical Nasal Reconstruction Versus Nasal Prosthesis (Epithesis) After Total or Subtotal Nasal Amputation (CERNAS)
Comparison of Epithesis and Surgical Nasal Reconstruction Using the SCHNOS Score
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Total or subtotal nasal amputation - defined as loss of at least three nasal subunits, or two subunits including the dorsum - results in major aesthetic and functional consequences with a significant impact on quality of life and social reintegration. Currently, two main rehabilitation approaches exist: surgical reconstruction (paramedian forehead flap as the gold standard, or free flaps such as the radial forearm free flap for larger defects) and nasal epithesis (implant-retained or adhesive prosthesis).
The choice between these techniques is often guided by the surgeon's experience and patient preference, in the absence of clear consensus, as very few studies have directly compared both options using standardised, patient-reported outcome measures.
The primary objective of this study is to compare functional and aesthetic outcomes between surgical reconstruction and epithesis groups using the SCHNOS questionnaire validated in French. Secondary objectives include comparison of subgroups by complications, comorbidities, patient profile, and identification of patients who switched rehabilitation modality.
Eligible patients will be identified via medical records by investigators at each participating centre. Those meeting inclusion criteria will be contacted by phone and then sent the information letter and questionnaire by mail or email. They may complete the questionnaire in paper form or via the secure Microsoft Forms platform. Questionnaire data will be exported to a centralised, password-protected Excel database for statistical analysis.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Laureline DESABRES, Doctor
- Numéro de téléphone: 01 30 75 40 40
- E-mail: laureline.desabres@ght-novo.fr
Sauvegarde des contacts de l'étude
- Nom: Khaled AL TABAA, Doctor
- E-mail: khaled.altabaa@ght-novo.fr
Lieux d'étude
-
-
-
Caen, France, 14033
- CHU de Caen
-
Chercheur principal:
- Maxime HUMBERT, Doctor
-
Paris, France, 75010
- Hôpital Lariboisière
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Contact:
- Benjamin VERILLAUD, Professor
- Numéro de téléphone: 0149958061
- E-mail: benjamin.verillaud@aphp.fr
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Chercheur principal:
- Benjamin VERILLAUD, Professor
-
Paris, France, 75014
- Groupe Hospitalier Paris St Joseph
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Chercheur principal:
- Vincent BEDARIDA, Doctor
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Pontoise, France
- Hopital Novo
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Contact:
- Laureline DESABRES, Doctor
- Numéro de téléphone: 01 30 75 40 40
- E-mail: laureline.desabres@ght-novo.fr
-
Chercheur principal:
- Laureline DESABRES, Doctor
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients aged 18 years or older
- Patients who have undergone total or subtotal nasal amputation (defined as loss of at least three nasal subunits, or of two subunits including the dorsum) and who have been rehabilitated either by surgical reconstruction or by nasal epithesis for more than one year
Exclusion Criteria:
- Ongoing tumour progression or tumour recurrence
- Non-French-speaking patients
- Patients under legal protection measures (guardianship, legal safeguarding, limited or full legal incapacity)
- Patients unlikely to cooperate with the study (e.g. presenting with a psychiatric disorder)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Surgical Reconstruction
Patient who has had nasal reconstruction
|
Total score on the validated French version of the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey) questionnaire, comparing surgical reconstruction versus epithesis groups after total or subtotal nasal amputation.
|
|
Nasal Epithesis
Patient who has had a nasal prosthesis
|
Total score on the validated French version of the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey) questionnaire, comparing surgical reconstruction versus epithesis groups after total or subtotal nasal amputation.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
SCHNOS total score
Délai: Single assessment at inclusion (at least 1 year after nasal reconstruction or epithesis placement)
|
Total score on the validated French version of the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey) questionnaire, comparing surgical reconstruction versus epithesis groups after total or subtotal nasal amputation.
|
Single assessment at inclusion (at least 1 year after nasal reconstruction or epithesis placement)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Subgroup comparison by complications and comorbidities
Délai: Single assessment at inclusion
|
Comparison of SCHNOS scores between subgroups defined by complications, comorbidities, and patient profile (age, sex, aetiology of amputation, treatment history).
|
Single assessment at inclusion
|
|
Description of Clinical Profiles
Délai: Single assessment at inclusion
|
Subgroup analysis of the profiles of patients who opted to change their rehabilitation treatment
|
Single assessment at inclusion
|
|
Benefit-risk balance of each rehabilitation technique
Délai: Single assessment at inclusion
|
Comparative analysis of each technique based on implementation modalities, time to rehabilitation, complications, and reversibility.
|
Single assessment at inclusion
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Laureline DESABRES, Doctor, Hopital Novo
- Chercheur principal: Benjamin VERILLAUD, Pr, Hôpital Lariboisière
- Chercheur principal: Vincent BEDARIDA, Doctor, Groupe Hospitalier Paris St Joseph
- Chercheur principal: Maxime HUMBERT, Doctor, University Hospital, Caen
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies osseuses
- Maladies musculo-squelettiques
- Tumeurs par site
- Tumeurs
- Maladies des voies respiratoires
- Tumeurs osseuses
- Tumeurs de la tête et du cou
- Tumeurs des voies respiratoires
- Maladies du nez
- Maladies oto-rhino-laryngologiques
- Tumeurs oto-rhino-laryngologiques
- Tumeurs du crâne
- Tumeurs du nez
Autres numéros d'identification d'étude
- 2026-A00866-45
- CHRD0826 (Autre identifiant: HOSPITAL NOVO)
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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