NCT07048418

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
OTHER	Mailing and completing CLEFT-Q and NOSE questionnaires	Mailing and completing CLEFT-Q and NOSE questionnaires

Timeline

• Start date: 2025-07-09
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-07-02
• Last updated: 2025-07-22

Locations

1 site across 1 country: France