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Набор скоро начнётся NCT07674030

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

— Наблюдательное Nose Cancer Rhinectomy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SCHNOS score.
Кому может быть актуально
Состояния в реестре: Nose Cancer, Rhinectomy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Comparison of Epithesis and Surgical Nasal Reconstruction Using the SCHNOS Score

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • SCHNOS total score [Срок оценки: Single assessment at inclusion (at least 1 year after nasal reconstruction or epithesis placement)]
Вторичные конечные точки (3)
  • Subgroup comparison by complications and comorbidities [Срок оценки: Single assessment at inclusion]
  • Description of Clinical Profiles [Срок оценки: Single assessment at inclusion]
  • Benefit-risk balance of each rehabilitation technique [Срок оценки: Single assessment at inclusion]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Франция · 4 центра
  • CHU de Caen — Caen
  • Hôpital LARIBOISIERE — Paris
  • Groupe Hospitalier Paris St Joseph — Paris
  • Hôpital NOVO — Pontoise

Идентификаторы

NCT: NCT07674030 · 2026-A00866-45 · CHRD0826

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗