Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT07048418
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}, {'id': 'D002972', 'term': 'Cleft Palate'}, {'id': 'D015508', 'term': 'Nasal Obstruction'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nasal Obstruction and Septoplasty Effectiveness (NOSE) Scale', 'timeFrame': 'At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)', 'description': '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.'}, {'measure': 'CLEFT-Q nose appearance', 'timeFrame': 'At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)', 'description': '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).'}, {'measure': 'CLEFT-Q nostrils appearance', 'timeFrame': 'At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)', 'description': '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).'}, {'measure': 'CLEFT-Q face appearance', 'timeFrame': 'At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Asher Mc Dade Score', 'timeFrame': 'At least 6 months after surgery', 'description': '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)'}, {'measure': 'Surgical complications according to the Clavien Dindo classification', 'timeFrame': 'few days after surgery', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rhinoplasty', 'septoplasty', 'rhinoseptoplasty', 'cleft', 'CLEFT-Q', 'nasal obstruction'], 'conditions': ['Cleft Lip and Cleft Palate']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nCleft 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.\n\nIn 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Unilateral cleft lip and palate patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nUnilateral 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.\n\nExclusion Criteria:\n\nIncomplete 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'}, 'identificationModule': {'nctId': 'NCT07048418', 'acronym': 'RHINOFENTE', 'briefTitle': 'Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate', 'orgStudyIdInfo': {'id': 'RECHMPL25_0017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group of cleft lip and palate patients who underwent rhinoseptoplasty in childhood or adolescence.', 'interventionNames': ['Other: Mailing and completing CLEFT-Q and NOSE questionnaires']}], 'interventions': [{'name': 'Mailing and completing CLEFT-Q and NOSE questionnaires', 'type': 'OTHER', 'description': 'Mailing and completing CLEFT-Q and NOSE questionnaires', 'armGroupLabels': ['Group of cleft lip and palate patients who underwent rhinoseptoplasty in childhood or adolescence.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295 MONTPELLIER', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume Pr Captier', 'role': 'CONTACT'}], 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Guillaume Captier, MD-PhD', 'role': 'CONTACT', 'email': 'g-captier@chu-montpellier.fr', 'phone': '+33467338761'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}