Rhinoplasty and Quality of Life

• Conditions: Quality of Life; Rhinoplasty

• Registration Number: NCT03519100
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2018-01-08
• Status Verified: 2018-04
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-25
• Last Update Submitted: 2018-04-25
• Study First Posted: 2018-05-08
• Last Update Posted: 2018-05-08
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change between the FACE-Q score	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

Secondary Outcome Measures

Name	Time	Method
Difference between the NOSE score	at the inclusion and 4 months post surgery	Difference between the NOSE score at the inclusion and 4 months after surgery
Difference between anthropometrics measures	before and immediate post surgery	Difference between anthropometrics measures of the nose before and after surgery

Trial Locations

Locations (1)

UH Bordeaux; 🇫🇷 Bordeaux, France