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

NCT07048418 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-07-22

No results posted yet for this study

Summary

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

  • Cleft Lip and Cleft Palate

Interventions

OTHER

Mailing and completing CLEFT-Q and NOSE questionnaires

Mailing and completing CLEFT-Q and NOSE questionnaires

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-09
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07048418 on ClinicalTrials.gov