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| ID | Type | Description | Link |
|---|---|---|---|
| CHRD0826 | Other Identifier | HOSPITAL NOVO |
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CERNAS is a prospective, multicenter, non-interventional study comparing the functional and aesthetic outcomes of two rehabilitation strategies after total or subtotal nasal amputation: surgical reconstruction (primarily paramedian forehead flap or free flap) versus nasal epithesis (prosthesis). Patients who have undergone either rehabilitation at least one year prior to enrolment will be invited to complete the validated French version of the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey) questionnaire. The study aims to provide an objective, patient-reported comparison of these two options to guide future clinical decision-making.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Reconstruction | Patient who has had nasal reconstruction |
| |
| Nasal Epithesis | Patient who has had a nasal prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCHNOS score | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| SCHNOS total score | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup comparison by complications and comorbidities | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patient who has undergone surgical or prosthetic nasal reconstruction following a total or subtotal nasal amputation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laureline DESABRES, Doctor | Contact | 01 30 75 40 40 | laureline.desabres@ght-novo.fr | |
| Khaled AL TABAA, Doctor | Contact | khaled.altabaa@ght-novo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Laureline DESABRES, Doctor | Hôpital NOVO | Principal Investigator |
| Benjamin VERILLAUD, Pr | Hôpital LARIBOISIERE | Principal Investigator |
| Vincent BEDARIDA, Doctor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Caen | Caen | 14033 | France |
|
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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 | Comparative analysis of each technique based on implementation modalities, time to rehabilitation, complications, and reversibility. | Single assessment at inclusion |
| Groupe Hospitalier Paris St Joseph |
| Principal Investigator |
| Maxime HUMBERT, Doctor | University Hospital, Caen | Principal Investigator |
| Hôpital LARIBOISIERE | Paris | 75010 | France |
|
| Groupe Hospitalier Paris St Joseph | Paris | 75014 | France |
|
| Hôpital NOVO | Pontoise | France |
|
| ID | Term |
|---|---|
| D009669 | Nose Neoplasms |
| ID | Term |
|---|---|
| D012888 | Skull Neoplasms |
| D001859 | Bone Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
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