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
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Laureline DESABRES, Doctor
- 电话号码：01 30 75 40 40
- 邮箱：laureline.desabres@ght-novo.fr
研究联系人备份
- 姓名：Khaled AL TABAA, Doctor
- 邮箱：khaled.altabaa@ght-novo.fr
学习地点
-
-
-
Caen、法国、14033
- CHU de Caen
-
首席研究员：
- Maxime HUMBERT, Doctor
-
Paris、法国、75010
- Hôpital Lariboisière
-
接触：
- Benjamin VERILLAUD, Professor
- 电话号码：0149958061
- 邮箱：benjamin.verillaud@aphp.fr
-
首席研究员：
- Benjamin VERILLAUD, Professor
-
Paris、法国、75014
- Groupe Hospitalier Paris St Joseph
-
首席研究员：
- Vincent BEDARIDA, Doctor
-
Pontoise、法国
- Hopital Novo
-
接触：
- Laureline DESABRES, Doctor
- 电话号码：01 30 75 40 40
- 邮箱：laureline.desabres@ght-novo.fr
-
首席研究员：
- Laureline DESABRES, Doctor
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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)
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
SCHNOS total score
大体时间：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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Subgroup comparison by complications and comorbidities
大体时间：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
大体时间：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
大体时间：Single assessment at inclusion
|
Comparative analysis of each technique based on implementation modalities, time to rehabilitation, complications, and reversibility.
|
Single assessment at inclusion
|
合作者和调查者
赞助
调查人员
- 首席研究员：Laureline DESABRES, Doctor、Hopital Novo
- 首席研究员：Benjamin VERILLAUD, Pr、Hôpital Lariboisière
- 首席研究员：Vincent BEDARIDA, Doctor、Groupe Hospitalier Paris St Joseph
- 首席研究员：Maxime HUMBERT, Doctor、University Hospital, Caen
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2026-A00866-45
- CHRD0826 (其他标识符：HOSPITAL NOVO)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.