Patients With Unilateral Cleft Lip With or Without Cleft PalateNCT04972370
A Proposal for a New Classification of Secondary Cleft Lip and Nose Deformities in Repaired Unilateral Cleft Lip
An observational study of Patients With Unilateral Cleft Lip With or Without Cleft Palate, run by Sohag University.
Trial summary
Congenital cleft lip with or without cleft palate is one of the most common congenital malformations with an estimated incidence of about 1 every 500 to 700 live births. Cleft lip and palate are caused by a complex combination of many environmental and genetic factors sharing into the etiology. Read more about this study
- Who is it for?
- Ages 3 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Unilateral Cleft Lip With or Without Cleft Palate
- What is being tested?
- Patients with Unilateral Cleft Lip with or without Cleft Palate
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with repaired unilateral cleft lip with or without cleft palate who had undergone primary cleft lip repair surgeries during their first year of life at Sohag University Hospital from January 2006 to December 2020.
Who may be able to join
None listed.
Who cannot join
- Patients with multiple cleft lip repair surgeries.
- If the primary cleft lip surgery was performed after the first year of life.
- Patients with no available photographs
About this study
Official title: Assessment of Secondary Cleft Lip and Nose Deformities in Patients With Repaired Unilateral Cleft Lip: A Proposal for a New Classification
Congenital cleft lip with or without cleft palate is one of the most common congenital malformations with an estimated incidence of about 1 every 500 to 700 live births. Cleft lip and palate are caused by a complex combination of many environmental and genetic factors sharing into the etiology. Patients with cleft lip and palate undergo multiple surgeries to reconstruct the anatomy and function to achieve symmetric, aesthetic, and functional nasolabial region. The most important goals of correction of the cleft are to achieve an acceptable facial appearance and psychological and social well-being for the patient and his or her family. Therefore, assessment of nasolabial appearance following cleft surgery remains an important parameter for evaluating the outcome of the procedure. Unfortunately, some residual deformities in the nasolabial region such as the abnormal shape of the nose, scar of the upper lip, uneven white roll, notched or excess vermilion border will remain noticeable. So, the assessment of secondary cleft nasolabial deformities needs a reliable rating scale. Although many scoring systems have been described in the literature, there is no globally accepted reliable one. A frequently used scoring system is the one proposed by Asher-McDade that uses frontal and lateral view masked prints of the nasolabial area. The use of three-dimensional (3D) imaging seems to be the most reliable in assessing cleft-related facial deformities. However, scoring based on two-dimensional (2D) photographs is easier to perform and more applicable in daily practice because all cleft patients are photographed during their treatment journey at predetermined intervals. Assessment of secondary nasolabial deformities in cleft patients in large numbers of patients helps compare the aesthetic results of the different treatment protocols and techniques.
- Being tested
- Patients with Unilateral Cleft Lip with or without Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with Unilateral Cleft Lip with or without Cleft PalateOther
2 dimensional Photographs of patients with unilateral cleft lip with or without cleft palate
| Study group | Role | What they receive |
|---|---|---|
| Patients with Unilateral Cleft Lip with or without Cleft Palate | Not described Receives: Other: Patients with Unilateral Cleft Lip with or without Cleft Palate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interrater reliability of a classification system that guides the need for secondary corrective surgery for patients with repaired unilateral cleft lip and having secondary cleft nasolabial deformities post-repair.
We compiled a photographic dataset of patients with secondary cleft nasolabial deformities post-repair. We developed a classification system of secondary deformities covering the key seven anatomical components, including nose, muscles, philtrum, lateral element, white roll, vermilion, and scar.
Independent expert surgeons will evaluate each secondary deformity identified in the photographic dataset using a scoring system ranging from 0-2. 0 indicates acceptable secondary deformity, which requires no further surgery; 1 indicates secondary deformity that only requires corrective surgery upon patient parents' preference; 2 indicates significant secondary deformity requiring corrective surgery. We will measure the interrater reliability of the classification system. An agreement of 0.8 or more across the independent expert assessors will render the classification system valid for further prospective validation and clinical application.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Jan 2006
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients With Unilateral Cleft Lip With or Without Cleft PalateStudies of the same condition, open and under way.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Labib Ebid-Allah, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972370
- Sponsor's protocol ID
- Soh-Med-21-07-08
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mossey PA, Little J, Munger RG, Dixon MJ, Shaw WC. Cleft lip and palate. Lancet. 2009 Nov 21;374(9703):1773-85. doi: 10.1016/S0140-6736(09)60695-4. Epub 2009 Sep 9.
PubMed 19747722Dixon MJ, Marazita ML, Beaty TH, Murray JC. Cleft lip and palate: understanding genetic and environmental influences. Nat Rev Genet. 2011 Mar;12(3):167-78. doi: 10.1038/nrg2933.
PubMed 21331089Russell KA, Orthod D, Tompson B, Orthod D, Paedo D. Correlation between facial morphology and esthetics in patients with repaired complete unilateral cleft lip and palate. Cleft Palate Craniofac J. 2009 May;46(3):319-25. doi: 10.1597/07-143.1. Epub 2008 Sep 27.
PubMed 19642746
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Secondary Cleft Lip and Nose Deformities in Patients With Repaired Unilateral Cleft Lip: A Proposal for a New Classification
- ClinicalTrials.gov ID
- NCT04972370
- Acronym / sponsor ID
- Soh-Med-21-07-08
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 Jul 2021 (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.
Congenital cleft lip with or without cleft palate is one of the most common congenital malformations with an estimated incidence of about 1 every 500 to 700 live births. Cleft lip and palate are caused by a complex combination of many environmental and genetic factors sharing into the etiology. Patients with cleft lip and palate undergo multiple surgeries to reconstruct the anatomy and function to achieve symmetric, aesthetic, and functional nasolabial region. The most important goals of correction of the cleft are to achieve an acceptable facial appearance and psychological and social well-being for the patient and his or her family. Therefore, assessment of nasolabial appearance following cleft surgery remains an important parameter for evaluating the outcome of the procedure. Unfortunately, some residual deformities in the nasolabial region such as the abnormal shape of the nose, scar of the upper lip, uneven white roll, notched or excess vermilion border will remain noticeable. So, the assessment of secondary cleft nasolabial deformities needs a reliable rating scale. Although many scoring systems have been described in the literature, there is no globally accepted reliable one. A frequently used scoring system is the one proposed by Asher-McDade that uses frontal and lateral view masked prints of the nasolabial area. The use of three-dimensional (3D) imaging seems to be the most reliable in assessing cleft-related facial deformities. However, scoring based on two-dimensional (2D) photographs is easier to perform and more applicable in daily practice because all cleft patients are photographed during their treatment journey at predetermined intervals. Assessment of secondary nasolabial deformities in cleft patients in large numbers of patients helps compare the aesthetic results of the different treatment protocols and techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Unilateral Cleft Lip with or without Cleft Palate | – | Other: Patients with Unilateral Cleft Lip with or without Cleft Palate |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with repaired unilateral cleft lip with or without cleft palate who had undergone primary cleft lip repair surgeries during their first year of life at Sohag University Hospital from January 2006 to December 2020.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients with multiple cleft lip repair surgeries.
- If the primary cleft lip surgery was performed after the first year of life.
- Patients with no available photographs
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 |
|---|---|---|
| Patients with Unilateral Cleft Lip with or without Cleft Palate2 dimensional Photographs of patients with unilateral cleft lip with or without cleft palate | Other | Patients with Unilateral Cleft Lip with or without Cleft Palate |
Primary outcome
Interrater reliability of a classification system that guides the need for secondary corrective surgery for patients with repaired unilateral cleft lip and having secondary cleft nasolabial deformities post-repair.
Time frame: 6 months
We compiled a photographic dataset of patients with secondary cleft nasolabial deformities post-repair. We developed a classification system of secondary deformities covering the key seven anatomical components, including nose, muscles, philtrum, lateral element, white roll, vermilion, and scar. Independent expert surgeons will evaluate each secondary deformity identified in the photographic dataset using a scoring system ranging from 0-2. 0 indicates acceptable secondary deformity, which requires no further surgery; 1 indicates secondary deformity that only requires corrective surgery upon patient parents' preference; 2 indicates significant secondary deformity requiring corrective surgery. We will measure the interrater reliability of the classification system. An agreement of 0.8 or more across the independent expert assessors will render the classification system valid for further prospective validation and clinical application.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Background: PubMed 19747722Mossey PA, Little J, Munger RG, Dixon MJ, Shaw WC. Cleft lip and palate. Lancet. 2009 Nov 21;374(9703):1773-85. doi: 10.1016/S0140-6736(09)60695-4. Epub 2009 Sep 9.
- Background: PubMed 21331089Dixon MJ, Marazita ML, Beaty TH, Murray JC. Cleft lip and palate: understanding genetic and environmental influences. Nat Rev Genet. 2011 Mar;12(3):167-78. doi: 10.1038/nrg2933.
- Background: PubMed 19642746Russell KA, Orthod D, Tompson B, Orthod D, Paedo D. Correlation between facial morphology and esthetics in patients with repaired complete unilateral cleft lip and palate. Cleft Palate Craniofac J. 2009 May;46(3):319-25. doi: 10.1597/07-143.1. Epub 2008 Sep 27.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Unilateral Cleft Lip With or Without Cleft Palate, run by Sohag University.
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 0 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interrater reliability of a classification system that guides the need for secondary corrective surgery for patients with repaired unilateral cleft lip and having secondary cleft nasolabial deformities post-repair. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04972370, which also lists 3 linked publications.
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 2021.