Actively Recruiting

Age: 18Years - 30Years
All Genders
NCT07048418

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

Age: 18Years - 30Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Montpellier

Montpellier, France, 34295 MONTPELLIER

Actively Recruiting

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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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Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate | DecenTrialz