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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Laureline DESABRES, Doctor
- Número de telefone: 01 30 75 40 40
- E-mail: laureline.desabres@ght-novo.fr
Estude backup de contato
- Nome: Khaled AL TABAA, Doctor
- E-mail: khaled.altabaa@ght-novo.fr
Locais de estudo
-
-
-
Caen, França, 14033
- CHU de Caen
-
Investigador principal:
- Maxime HUMBERT, Doctor
-
Paris, França, 75010
- Hôpital Lariboisière
-
Contato:
- Benjamin VERILLAUD, Professor
- Número de telefone: 0149958061
- E-mail: benjamin.verillaud@aphp.fr
-
Investigador principal:
- Benjamin VERILLAUD, Professor
-
Paris, França, 75014
- Groupe Hospitalier Paris St Joseph
-
Investigador principal:
- Vincent BEDARIDA, Doctor
-
Pontoise, França
- Hopital Novo
-
Contato:
- Laureline DESABRES, Doctor
- Número de telefone: 01 30 75 40 40
- E-mail: laureline.desabres@ght-novo.fr
-
Investigador principal:
- Laureline DESABRES, Doctor
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
SCHNOS total score
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Subgroup comparison by complications and comorbidities
Prazo: 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
Prazo: 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
Prazo: Single assessment at inclusion
|
Comparative analysis of each technique based on implementation modalities, time to rehabilitation, complications, and reversibility.
|
Single assessment at inclusion
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Laureline DESABRES, Doctor, Hopital Novo
- Investigador principal: Benjamin VERILLAUD, Pr, Hôpital Lariboisière
- Investigador principal: Vincent BEDARIDA, Doctor, Groupe Hospitalier Paris St Joseph
- Investigador principal: Maxime HUMBERT, Doctor, University Hospital, Caen
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
- 2026-A00866-45
- CHRD0826 (Outro identificador: HOSPITAL NOVO)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .