NCT03519100

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 8, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

April 5, 2018

Last Update Submit

April 25, 2018

Conditions

RhinoplastyQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Difference between the NOSE score

    at the inclusion and 4 months post surgery

  • Difference between anthropometrics measures

    before and immediate post surgery

Interventions

quality of life evaluationOTHER

quality of life evaluation post surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients will involved during surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Bordeaux

Bordeaux, 33000, France

RECRUITING

Study Officials

  • de GABORY Ludovic

    University Hospital, Bordeaux

    STUDY DIRECTOR

Central Study Contacts

HERON Antoine

CONTACT

33 556795679antoine.heron.med@gmail.com

de GABORY Ludovic

CONTACT

33 556795679ludovic.de-gabory@chu-bordeaux.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2018

First Posted

May 8, 2018

Study Start

January 8, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 8, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)