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临床试验/NCT07674030
NCT07674030尚未招募不适用

Comparison of Epithesis and Surgical Nasal Reconstruction Using the SCHNOS Score

Hôpital NOVO4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
4
主要终点
SCHNOS total score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Nasal Epithesis

Patient who has had a nasal prosthesis

干预措施: SCHNOS score (Other)

Surgical Reconstruction

Patient who has had nasal reconstruction

干预措施: SCHNOS score (Other)

结局指标

主要结局

SCHNOS total score

时间窗: 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.

次要结局

  • Subgroup comparison by complications and comorbidities(Single assessment at inclusion)
  • Description of Clinical Profiles(Single assessment at inclusion)
  • Benefit-risk balance of each rehabilitation technique(Single assessment at inclusion)

研究者

发起方
Hôpital NOVO
申办方类型
Other
责任方
Sponsor

研究点 (4)

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