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

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

Study Contact Backup

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.

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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