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

Comparison of Epithesis and Surgical Nasal Reconstruction Using the SCHNOS Score

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07674030
Acronym
CERNAS
Enrollment
20
Registered
2026-06-29
Start date
2026-07-01
Completion date
2027-01-30
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nose Cancer, Rhinectomy

Keywords

Total rhinectomy, Nasal reconstruction, Nasal prosthesis, SCHNOS, Nasal amputation, Quality of life, Free flap, Forehead flap

Brief summary

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.

Detailed description

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.

Interventions

OTHERSCHNOS 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.

Sponsors

Hôpital NOVO
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
SCHNOS total scoreSingle 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

MeasureTime frameDescription
Subgroup comparison by complications and comorbiditiesSingle assessment at inclusionComparison of SCHNOS scores between subgroups defined by complications, comorbidities, and patient profile (age, sex, aetiology of amputation, treatment history).
Description of Clinical ProfilesSingle assessment at inclusionSubgroup analysis of the profiles of patients who opted to change their rehabilitation treatment
Benefit-risk balance of each rehabilitation techniqueSingle assessment at inclusionComparative analysis of each technique based on implementation modalities, time to rehabilitation, complications, and reversibility.

Countries

France

Contacts

CONTACTLaureline DESABRES, Doctor
laureline.desabres@ght-novo.fr01 30 75 40 40
CONTACTKhaled AL TABAA, Doctor
khaled.altabaa@ght-novo.fr
PRINCIPAL_INVESTIGATORLaureline DESABRES, Doctor

Hôpital NOVO

PRINCIPAL_INVESTIGATORBenjamin VERILLAUD, Pr

Hôpital LARIBOISIERE

PRINCIPAL_INVESTIGATORVincent BEDARIDA, Doctor

Groupe Hospitalier Paris St Joseph

PRINCIPAL_INVESTIGATORMaxime HUMBERT, Doctor

University Hospital, Caen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026