RHINOFENTE
Sponsor study identifier
observational
80
1 country
1
Study Start
July 9, 2025
Actual (reported)Primary Completion
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 19, 2025
Actual (reported)July 2, 2025
Actual (reported)July 9, 2025
Actual (reported)July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
Asher Mc Dade Score
At least 6 months after surgery
Surgical complications according to the Clavien Dindo classification
few days after surgery
Mailing and completing CLEFT-Q and NOSE questionnaires
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Unilateral cleft lip and palate patients
CHU Montpellier
Montpellier, 34295 MONTPELLIER, France
First Submitted
June 19, 2025
First Posted
July 2, 2025
Study Start
July 9, 2025
Actual (reported)Primary Completion
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
Contact the study team to confirm eligibility.
Study Completion
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 22, 2025
Record last verified: 2025-07
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Source: ClinicalTrials.gov.
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