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

NCT07674030 — Not yet recruiting, 20 participants, Hôpital NOVO

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Comparison of Epithesis and Surgical Nasal Reconstruction Using the SCHNOS Score

RegistryNCT07674030, acronym CERNAS
StatusNot yet recruiting
Study typeObservational
Enrollment20 (Estimated)
SponsorHôpital NOVO (Other)
ConditionsNose Cancer, Rhinectomy
InterventionsSCHNOS score (Other)
Datesstart 2026-07-01 (estimated), primary completion 2027-01-02 (estimated), completion 2027-01-30 (estimated), first posted 2026-06-29, last updated 2026-07-01
Locations4 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for Nose Cancer All trials for Rhinectomy All trials of SCHNOS score

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Surgical ReconstructionOther: SCHNOS scorePatient who has had nasal reconstruction
Nasal EpithesisOther: SCHNOS scorePatient who has had a nasal prosthesis
  • 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.

+Outcome measures

Primary outcomes

  • SCHNOS total score [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

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

+Eligibility

Sex: All, ages: 18 Years to any

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)

+Locations (4)

FacilityCityCountryStatus
CHU de CaenCaenFrance
Hôpital LARIBOISIEREParisFrance
Groupe Hospitalier Paris St JosephParisFrance
Hôpital NOVOPontoiseFrance

+Investigators

  • Laureline DESABRES, Doctor, Principal investigator, Hôpital NOVO
  • Benjamin VERILLAUD, Pr, Principal investigator, Hôpital LARIBOISIERE
  • Vincent BEDARIDA, Doctor, Principal investigator, Groupe Hospitalier Paris St Joseph
  • Maxime HUMBERT, Doctor, Principal investigator, University Hospital, Caen