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NCT Number: NCT07674030

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Caen, Caen, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. SCHNOS total score

    Time frame: 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.

Secondary outcomes

  1. Subgroup comparison by complications and comorbidities

    Time frame: Single assessment at inclusion

    Comparison of SCHNOS scores between subgroups defined by complications, comorbidities, and patient profile (age, sex, aetiology of amputation, treatment history).

  2. Description of Clinical Profiles

    Time frame: Single assessment at inclusion

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

  3. Benefit-risk balance of each rehabilitation technique

    Time frame: Single assessment at inclusion

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

Study contacts

Contact information is provided by the study sponsor or research team.

Khaled AL TABAA, Doctor

CONTACT

[email protected]

Laureline DESABRES, Doctor

CONTACT

[email protected]

01 30 75 40 40

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

Comparison of Epithesis and Surgical Nasal Reconstruction Using the SCHNOS Score

Acronym: CERNAS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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