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

29. juni 2026 opdateret af: Hôpital NOVO

Comparison of Epithesis and Surgical Nasal Reconstruction Using the SCHNOS Score

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

20

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
      • Caen, Frankrig, 14033
        • CHU de Caen
        • Ledende efterforsker:
          • Maxime HUMBERT, Doctor
      • Paris, Frankrig, 75010
        • Hopital Lariboisiere
        • Kontakt:
        • Ledende efterforsker:
          • Benjamin VERILLAUD, Professor
      • Paris, Frankrig, 75014
        • Groupe Hospitalier Paris St Joseph
        • Ledende efterforsker:
          • Vincent BEDARIDA, Doctor
      • Pontoise, Frankrig
        • Hôpital NOVO
        • Kontakt:
        • Ledende efterforsker:
          • Laureline DESABRES, Doctor

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patient who has undergone surgical or prosthetic nasal reconstruction following a total or subtotal nasal amputation.

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Surgical Reconstruction
Patient who has had nasal reconstruction
Andet: SCHNOS 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.
Nasal Epithesis
Patient who has had a nasal prosthesis
Andet: SCHNOS 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
SCHNOS total score
Tidsramme: 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.
Single assessment at inclusion (at least 1 year after nasal reconstruction or epithesis placement)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subgroup comparison by complications and comorbidities
Tidsramme: Single assessment at inclusion
Comparison of SCHNOS scores between subgroups defined by complications, comorbidities, and patient profile (age, sex, aetiology of amputation, treatment history).
Single assessment at inclusion
Description of Clinical Profiles
Tidsramme: Single assessment at inclusion
Subgroup analysis of the profiles of patients who opted to change their rehabilitation treatment
Single assessment at inclusion
Benefit-risk balance of each rehabilitation technique
Tidsramme: Single assessment at inclusion
Comparative analysis of each technique based on implementation modalities, time to rehabilitation, complications, and reversibility.
Single assessment at inclusion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hôpital NOVO

Efterforskere

  • Ledende efterforsker: Laureline DESABRES, Doctor, Hôpital NOVO
  • Ledende efterforsker: Benjamin VERILLAUD, Pr, Hopital Lariboisiere
  • Ledende efterforsker: Vincent BEDARIDA, Doctor, Groupe Hospitalier Paris St Joseph
  • Ledende efterforsker: Maxime HUMBERT, Doctor, University Hospital, Caen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

2. januar 2027

Studieafslutning (Anslået)

30. januar 2027

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

23. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-A00866-45
  • CHRD0826 (Anden identifikator: HOSPITAL NOVO)

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Næsekræft

Kliniske forsøg med SCHNOS score

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