About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Patient who has undergone surgical or prosthetic nasal reconstruction following a total or subtotal nasal amputation.
Trial design
Case-control
Prospective
Treatments tested in this trial
SCHNOS score
Other interventionTotal 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
Description of Clinical Profiles
Subgroup analysis of the profiles of patients who opted to change their rehabilitation treatment
Benefit-risk balance of each rehabilitation technique
Comparative analysis of each technique based on implementation modalities, time to rehabilitation, complications, and reversibility.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: