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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Laureline DESABRES, Doctor
- 전화번호: 01 30 75 40 40
- 이메일: laureline.desabres@ght-novo.fr
연구 연락처 백업
- 이름: Khaled AL TABAA, Doctor
- 이메일: khaled.altabaa@ght-novo.fr
연구 장소
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-
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Caen, 프랑스, 14033
- CHU de Caen
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수석 연구원:
- Maxime HUMBERT, Doctor
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Paris, 프랑스, 75010
- Hôpital Lariboisière
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연락하다:
- Benjamin VERILLAUD, Professor
- 전화번호: 0149958061
- 이메일: benjamin.verillaud@aphp.fr
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수석 연구원:
- Benjamin VERILLAUD, Professor
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Paris, 프랑스, 75014
- Groupe Hospitalier Paris St Joseph
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수석 연구원:
- Vincent BEDARIDA, Doctor
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Pontoise, 프랑스
- Hopital Novo
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연락하다:
- Laureline DESABRES, Doctor
- 전화번호: 01 30 75 40 40
- 이메일: laureline.desabres@ght-novo.fr
-
수석 연구원:
- Laureline DESABRES, Doctor
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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
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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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
SCHNOS total score
기간: Single assessment at inclusion (at least 1 year after nasal reconstruction or epithesis placement)
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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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Subgroup comparison by complications and comorbidities
기간: 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
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Description of Clinical Profiles
기간: Single assessment at inclusion
|
Subgroup analysis of the profiles of patients who opted to change their rehabilitation treatment
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Single assessment at inclusion
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Benefit-risk balance of each rehabilitation technique
기간: Single assessment at inclusion
|
Comparative analysis of each technique based on implementation modalities, time to rehabilitation, complications, and reversibility.
|
Single assessment at inclusion
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Laureline DESABRES, Doctor, Hopital Novo
- 수석 연구원: Benjamin VERILLAUD, Pr, Hôpital Lariboisière
- 수석 연구원: Vincent BEDARIDA, Doctor, Groupe Hospitalier Paris St Joseph
- 수석 연구원: Maxime HUMBERT, Doctor, University Hospital, Caen
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-A00866-45
- CHRD0826 (기타 식별자: HOSPITAL NOVO)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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