Functional and Aesthetic Comparison of Surgical Nasal Reconstruction Versus Nasal Prosthesis (Epithesis) After Total or Subtotal Nasal Amputation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpital NOVO

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • SCHNOS score

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Surgical Reconstruction1 intervention
Group B: Nasal Epithesis1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Single assessment at inclusion (at least 1 year after nasal reconstruction or epithesis placement)

Secondary outcomes

1

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).

Time frame
Single assessment at inclusion
2

Description of Clinical Profiles

Subgroup analysis of the profiles of patients who opted to change their rehabilitation treatment

Time frame
Single assessment at inclusion
3

Benefit-risk balance of each rehabilitation technique

Comparative analysis of each technique based on implementation modalities, time to rehabilitation, complications, and reversibility.

Time frame
Single assessment at inclusion

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: