Aesthetic and breathing outcomes after secondary rhinoseptoplasty for people with one-sided cleft lip and palate
Official title: Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate
Run by University Hospital, Montpellier · NCT07048418 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 30 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Status | Recruiting |
| Started | July 9, 2025 |
| Main results expected | July 1, 2026 |
| Study ends | July 1, 2026 |
| Registry record updated | July 22, 2025 |
| Trial ID | NCT07048418 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
CHU Montpellier
Montpellier, France Recruiting
Study contacts
- Study coordinator: Guillaume Captier, MD-PhD
- Email: g-captier@chu-montpellier.fr
- Phone: +33467338761
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.