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ClinicalTrials.gov ID

NCT07674030

Lead Sponsor

Hôpital NOVOOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

20Estimated

Last Update Posted

Jul 1, 2026Actual

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Jan 2, 2027Estimated

Completion Date

Jan 30, 2027Estimated

Official Title

Comparison of Epithesis and Surgical Nasal Reconstruction Using the SCHNOS Score

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.

• Nose Cancer
• Rhinectomy

• SCHNOS score

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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)

Observational Model

Case-Control

Time Perspective

Prospective

Lead Sponsor

Hôpital NOVOOTHER

benjamin.verillaud@aphp.fr0149958061

laureline.desabres@ght-novo.fr01 30 75 40 40