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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group of cleft lip and palate patients who underwent rhinoseptoplasty in childhood or adolescence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mailing and completing CLEFT-Q and NOSE questionnaires | Other | Mailing and completing CLEFT-Q and NOSE questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Asher Mc Dade Score | 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) | At least 6 months after surgery |
| Surgical complications according to the Clavien Dindo classification |
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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
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Unilateral cleft lip and palate patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume Captier, MD-PhD | Contact | +33467338761 | g-captier@chu-montpellier.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Montpellier | Recruiting | Montpellier | 34295 MONTPELLIER | France |
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| D002972 | Cleft Palate |
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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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. |
| few days after surgery |
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |