Functional and Aesthetic Comparison of Surgical Nasal Reconstruction Versus Nasal Prosthesis (Epithesis) After Total or Subtotal Nasal Amputation (CERNAS)
Comparison of Epithesis and Surgical Nasal Reconstruction Using the SCHNOS Score
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Laureline DESABRES, Doctor
- 電話番号：01 30 75 40 40
- メール：laureline.desabres@ght-novo.fr
研究連絡先のバックアップ
- 名前：Khaled AL TABAA, Doctor
- メール：khaled.altabaa@ght-novo.fr
研究場所
-
-
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Caen、フランス、14033
- CHU de Caen
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主任研究者：
- Maxime HUMBERT, Doctor
-
Paris、フランス、75010
- Hôpital Lariboisière
-
コンタクト：
- Benjamin VERILLAUD, Professor
- 電話番号：0149958061
- メール：benjamin.verillaud@aphp.fr
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主任研究者：
- Benjamin VERILLAUD, Professor
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Paris、フランス、75014
- Groupe Hospitalier Paris St Joseph
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主任研究者：
- Vincent BEDARIDA, Doctor
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Pontoise、フランス
- Hopital Novo
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コンタクト：
- Laureline DESABRES, Doctor
- 電話番号：01 30 75 40 40
- メール：laureline.desabres@ght-novo.fr
-
主任研究者：
- Laureline DESABRES, Doctor
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Surgical Reconstruction
Patient who has had nasal reconstruction
|
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
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
SCHNOS total score
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Subgroup comparison by complications and comorbidities
時間枠：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
時間枠：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
時間枠：Single assessment at inclusion
|
Comparative analysis of each technique based on implementation modalities, time to rehabilitation, complications, and reversibility.
|
Single assessment at inclusion
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Laureline DESABRES, Doctor、Hopital Novo
- 主任研究者：Benjamin VERILLAUD, Pr、Hôpital Lariboisière
- 主任研究者：Vincent BEDARIDA, Doctor、Groupe Hospitalier Paris St Joseph
- 主任研究者：Maxime HUMBERT, Doctor、University Hospital, Caen
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2026-A00866-45
- CHRD0826 (その他の識別子：HOSPITAL NOVO)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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