Aesthetic and breathing outcomes after secondary rhinoseptoplasty for people with one-sided cleft lip and palate
Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate
Adults who had a unilateral cleft lip and palate and later underwent secondary rhinoseptoplasty are asked to complete questionnaires to see if the surgery improved how their nose looks and how well they breathe through it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT07048418 on ClinicalTrials.gov |
What this trial studies
This observational project contacts adults aged 18–30 who had primary unilateral cleft repair at Montpellier University Hospital and a secondary rhinoseptoplasty there in childhood or adolescence. Participants receive the CLEFT-Q and NOSE questionnaires by mail to report aesthetic satisfaction and nasal function. Responses will be analyzed descriptively against surgical history and patient characteristics. The aim is to document patient-reported functional and aesthetic outcomes in this specific unilateral cleft population.
Who should consider this trial
Good fit: Ideal candidates are 18–30-year-old adults with unilateral cleft lip and palate who had primary repair before 12 months of age and a secondary rhinoseptoplasty at CHU Montpellier.
Not a fit: Patients who had primary surgery elsewhere, prior nasal operations, incomplete records, inability to read or write, legal protection status, or who are pregnant or breastfeeding are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could give patients and surgeons clearer expectations about how secondary rhinoseptoplasty affects nasal appearance and breathing.
How similar studies have performed: The CLEFT-Q and NOSE are validated patient-reported outcome tools and have been useful in cleft care, but few published reports specifically document outcomes after secondary rhinoseptoplasty in unilateral cleft patients, so direct evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montpellier
- CHU Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Guillaume Captier, MD-PhD
- Email: g-captier@chu-montpellier.fr
- Phone: +33467338761
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.