Rhinoplasty and Quality of Life

Quality of Life Clinical Trial

— FACE-Q  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03519100
• Other study ID #: CHUBX 2017/40
• Status: Recruiting
• Start date: January 8, 2018
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: University Hospital, Bordeaux
• Contact: HERON Antoine
• Phone: 33 556795679
• Email: antoine.heron.med[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life
• Rhinoplasty

Intervention

Other:
• quality of life evaluation
quality of life evaluation post surgery

Locations

Country	Name	City	State
France	UH Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change between the FACE-Q score	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	at the inclusion, one week later and 4 months after surgery
Secondary	Difference between the NOSE score	Difference between the NOSE score at the inclusion and 4 months after surgery	at the inclusion and 4 months post surgery
Secondary	Difference between anthropometrics measures	Difference between anthropometrics measures of the nose before and after surgery	before and immediate post surgery