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

NCT07048418 | Recruiting

• 1 other identifier: RECHMPL25_0017
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

rhinoplasty; septoplasty; rhinoseptoplasty; cleft; CLEFT-Q; nasal obstruction

Outcome Measures

Primary Outcomes (4)

• Nasal Obstruction and Septoplasty Effectiveness (NOSE) Scale

  The Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE) consists of 5 items with 5 modalities (from 0 to 4) with higher scores indicating more severe symptoms : nasal congestion, nasal obstruction, difficulty breathing through the nose, sleep disturbance and breathing difficulties during exercise.

  At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)

• CLEFT-Q nose appearance

  A raw score is first calculated as the sum of the scale items, then rescaled from a conversion table into a score from 0 (worst) to 100 (best).

  At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)

• CLEFT-Q nostrils appearance

  A raw score is first calculated as the sum of the scale items, then rescaled from a conversion table into a score from 0 (worst) to 100 (best).

  At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)

• CLEFT-Q face appearance

  A raw score is first calculated as the sum of the scale items, then rescaled from a conversion table into a score from 0 (worst) to 100 (best).

  At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)

Secondary Outcomes (2)

• Asher Mc Dade Score

  At least 6 months after surgery

• Surgical complications according to the Clavien Dindo classification

  few days after surgery

Study Arms (1)

Group of cleft lip and palate patients who underwent rhinoseptoplasty in childhood or adolescence.

Other: Mailing and completing CLEFT-Q and NOSE questionnaires

Interventions

Mailing and completing CLEFT-Q and NOSE questionnaires OTHER

Mailing and completing CLEFT-Q and NOSE questionnaires

Group of cleft lip and palate patients who underwent rhinoseptoplasty in childhood or adolescence.

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Unilateral cleft lip and palate patients

You may qualify if:

• Unilateral cleft lip and palate Surgery performed at the university hospital as primary surgery (before 12 months of age) without rhino-septoplasty Rhino-septoplasty performed at the university hospital as secondary surgery in childhood or adolescence Aged between 18 and 30 years at the time the CLEFT Q questionnaire was sent out.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34295 MONTPELLIER, France

RECRUITING

MeSH Terms

Conditions

Cleft Lip; Cleft Palate; Nasal Obstruction

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Central Study Contacts

Guillaume Captier, MD-PhD

CONTACT

+33467338761; g-captier@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 2, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

FR (1)