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

Not yet recruiting

• Conditions: Cleft Lip and Cleft Palate

• Registration Number: NCT07048418
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study Start: 2025-07-01
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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.

Exclusion Criteria

Incomplete clinical file Primary operation elsewhere than at the Montpellier University Hospital Other operation on the nose prior to rhinoseptoplasty Subject unable to read and/or write Impossibility of following the patient during the study period Opposition to participation after a period of reflection Non affiliation to a social security scheme Persons subject to a legal protection measure (placed under safeguard of justice, persons under guardianship or curatorship), Persons participating in another research study including an exclusion period still in progress Pregnant or breast-feeding women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nasal Obstruction and Septoplasty Effectiveness (NOSE) Scale	At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)	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.
CLEFT-Q nose appearance	At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)	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).
CLEFT-Q nostrils appearance	At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)	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).
CLEFT-Q face appearance	At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)	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).

Secondary Outcome Measures

Name	Time	Method
Asher Mc Dade Score	At least 6 months after surgery	The aesthetic result is assessed on the basis of photographs (from the medical file) of the face, profile and lower view of the face before/after surgery, using the Asher-McDade method (score from 3 : best appearance to 15 : worst appearance)
Surgical complications according to the Clavien Dindo classification	few days after surgery	The Clavien-Dindo classification ranges from Grade 1 (minor deviation from normal recovery without pharmacological treatment) to Grade 5 (death). Grade 2 involves complications requiring drugs like antibiotics or blood transfusions. Grade 3 includes complications requiring surgical, endoscopic, or radiological intervention (IIIa without general anesthesia, IIIb with). Grade 4 refers to life-threatening complications needing ICU care (IVa single organ failure, IVb multi-organ). This system standardizes reporting and allows comparison of surgical outcomes.