Actively Recruiting
Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate
Led by University Hospital, Montpellier · Updated on 2025-07-22
80
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Secondary rhino-septoplasty in unilateral cleft lip and palate is the treatment of choice for the correction of aesthetic deformities and the functional impact on ventilation nasal. It remains a difficult treatment. It can be proposed at the end of growth or from the age of 10, depending on nasal obstruction and the severity of the deformity. The CLEFT-Q questionnaire, validated in 2017, has not yet been widely used in studies. The NOSE questionnaire is an older functional questionnaire that is complementary to the CLEFT-Q. Cleft lip and palate are rare diseases, accounting for around 30% of all facial clefts, which occur at a rate of 1/750 births in Europe. Deformation of the nose and nasal septum is constant, and more or less severe in unilateral forms. In the absence of rhino-septoplasty performed during primary cleft repair surgery, deformities persist in children and adolescents. There is a significant aesthetic impact in children, which generally increases in adolescents. The problem of nasal obstruction causes functional discomfort that can be disabling. Open rhino-septoplasty is a standard procedure and is proposed as a secondary treatment in this population . It is indicated during growth in cases of nasal obstruction, or as a function of aesthetic demands. The hypothesis is that secondary rhino-septoplasty gives long-term satisfaction in patients in terms of aesthetics and respiratory function. The originality of this study lies in the use of the recently validated CLEFT-Q questionnaire to assess the aesthetic and functional satisfaction of patients in adulthood after secondary rhino-septoplasty performed in childhood or adolescence. This long-term follow-up will enable us to assess the stability of aesthetic and functional results.
CONDITIONS
Official Title
Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral cleft lip and palate
- Primary surgery performed at the university hospital before 12 months of age without rhino-septoplasty
- Secondary rhino-septoplasty performed at the university hospital in childhood or adolescence
- Aged between 18 and 30 years at the time of questionnaire completion
You will not qualify if you...
- Incomplete clinical file
- Primary surgery performed outside Montpellier University Hospital
- Any other nasal surgery before rhinoseptoplasty
- Unable to read and/or write
- Unable to be followed during the study period
- Opposed to participation after reflection
- Not affiliated with a social security scheme
- Under legal protection measures (guardianship, curatorship, or safeguard of justice)
- Participating in another research study with an ongoing exclusion period
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU Montpellier
Montpellier, France, 34295 MONTPELLIER
Actively Recruiting
Research Team
G
Guillaume Captier, MD-PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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