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临床试验/NCT03519100
NCT03519100Unknown不适用

Rhinoplasty and Quality of Life: Prospective Multicenter Study Before and After Surgery

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Change between the FACE-Q score

研究概览

简要总结

Quality of life and satisfaction in aesthetic surgery is still under-evaluated. It is a prospective and multicenter study with a 4 months follow-up of patients under rhinoplasty or rhinoseptoplasty procedure. They will answer to the FACE-Q and NOSE questionnaires before surgery, one week later and 4 months after the procedure. The aim of the study is to show a significant augmentation of the quality of life scores. At this occasion, the FACE-Q questionnaire has been translated and validated in French

详细描述

The main objective of this study is to show the efficiency of the rhinoplasty or rhinoseptoplasty procedure on the quality of life in a French population. There are many Patients reported outcomes questionnaire in aesthetic surgery but none of them is perfect. The FACE-Q rhinoplasty modules questionnaires is a recent test which has been validated in English but not in French. It is able to evaluate different areas of the quality of life and patient satisfaction. After French validation of the FACE-Q, this study will compare patient satisfaction before and after rhinoplasty or rhinoseptoplasty procedure. There is a lack of studies in the French population about rhinoseptoplasty surgery and quality of life or satisfaction. The goal is to show the interest of a surgery procedure on the feeling of the patients, concerning very different domains of appearance. This could help us to define the preoperative patients who are able to be really improved by this surgery

研究设计

研究类型
Observational
观察模型
Cohort
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

  • at least 18 years old,
  • patient engaged for surgery procedure of rhinoplasty or rhinoseptoplasty

排除标准

  • patient with nose surgery medical history,
  • mental or physical incapacity to answer the questionnaires
  • antecedent of cervico facial cancer

结局指标

主要结局

Change between the FACE-Q score

时间窗: at the inclusion, one week later and 4 months after surgery

Change between the FACE-Q score at the inclusion, one week later and 4 months after surgery. The minimal clinical importance difference has to be determinate thanks to the validation process of the FACE-Q in French

次要结局

  • Difference between the NOSE score(at the inclusion and 4 months post surgery)
  • Difference between anthropometrics measures(before and immediate post surgery)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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