- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03519100
Rhinoplasty and Quality of Life (FACE-Q)
April 25, 2018 updated by: University Hospital, Bordeaux
Rhinoplasty and Quality of Life: Prospective Multicenter Study Before and After Surgery
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: HERON Antoine
- Phone Number: 95475 33 556795679
- Email: antoine.heron.med@gmail.com
Study Contact Backup
- Name: de GABORY Ludovic
- Phone Number: 95475 33 556795679
- Email: ludovic.de-gabory@chu-bordeaux.fr
Study Locations
-
-
-
Bordeaux, France, 33000
- Recruiting
- UH Bordeaux
-
Contact:
- HERON Antoine
- Phone Number: 95475 33 556795679
-
Principal Investigator:
- de GABORY Ludovic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients will involved during surgery
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change between the FACE-Q score
Time Frame: 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
|
at the inclusion, one week later and 4 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference between the NOSE score
Time Frame: at the inclusion and 4 months post surgery
|
Difference between the NOSE score at the inclusion and 4 months after surgery
|
at the inclusion and 4 months post surgery
|
Difference between anthropometrics measures
Time Frame: before and immediate post surgery
|
Difference between anthropometrics measures of the nose before and after surgery
|
before and immediate post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: de GABORY Ludovic, UH Bordeaux
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2018
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
April 5, 2018
First Submitted That Met QC Criteria
April 25, 2018
First Posted (Actual)
May 8, 2018
Study Record Updates
Last Update Posted (Actual)
May 8, 2018
Last Update Submitted That Met QC Criteria
April 25, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- CHUBX 2017/40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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