Cleft Lip and Cleft PalateRHINOFENTENCT07048418
Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate
An observational study of Cleft Lip and Cleft Palate, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Cleft Lip and Cleft Palate
- What is being tested?
- Mailing and completing CLEFT-Q and NOSE questionnaires
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: Unilateral cleft lip and palate patients
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Montpellier
Montpellier, 34295 MONTPELLIER
Guillaume Pr Captier
About this study
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.
Read more
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.
- Conditions
- Cleft Lip and Cleft Palate
- Being tested
- Mailing and completing CLEFT-Q and NOSE questionnaires
- Keywords
- rhinoplasty, septoplasty, rhinoseptoplasty, cleft, CLEFT-Q, nasal obstruction
- Medical subject headings
- Cleft Lip, Cleft Palate, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailing and completing CLEFT-Q and NOSE questionnairesOther
Mailing and completing CLEFT-Q and NOSE questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Group of cleft lip and palate patients who underwent rhinoseptoplasty in childhood or adolescence. | Not described Receives: Other: Mailing and completing CLEFT-Q and NOSE questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)
Secondary outcomes (2)
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)
Measured: At least 6 months after surgery
Surgical complications according to the Clavien Dindo classification
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.
Measured: few days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start9 Jul 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and Cleft PalateStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048418
- Sponsor's protocol ID
- RECHMPL25_0017
- Acronym
- RHINOFENTE
- Status last verified
- Jul 2025
- First submitted
- 19 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate
- ClinicalTrials.gov ID
- NCT07048418
- Acronym / sponsor ID
- RHINOFENTE / RECHMPL25_0017
- Conditions
- Cleft Lip and Cleft Palate
- Keywords
- rhinoplasty, septoplasty, rhinoseptoplasty, cleft, CLEFT-Q, nasal obstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group of cleft lip and palate patients who underwent rhinoseptoplasty in childhood or adolescence. | – | Other: Mailing and completing CLEFT-Q and NOSE questionnaires |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Unilateral cleft lip and palate patients
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mailing and completing CLEFT-Q and NOSE questionnairesMailing and completing CLEFT-Q and NOSE questionnaires | Other | Group of cleft lip and palate patients who underwent rhinoseptoplasty in childhood or adolescence. |
Primary outcome
Nasal Obstruction and Septoplasty Effectiveness (NOSE) Scale
Time frame: At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)
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.
CLEFT-Q nose appearance
Time frame: At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)
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).
CLEFT-Q nostrils appearance
Time frame: At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)
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).
CLEFT-Q face appearance
Time frame: At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)
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).
2 secondary outcomes
Asher Mc Dade Score
Time frame: At least 6 months after surgery
Surgical complications according to the Clavien Dindo classification
Time frame: few days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Lip and Cleft Palate, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Captier, MD-PhD (+33467338761, g-captier@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Obstruction and Septoplasty Effectiveness (NOSE) Scale (time frame: At inclusion (i.e. 3 to 20 years after surgery, according to inclusion criteria)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.