Clinical trial NCT04972370: A Proposal for a New Classification of Secondary Cleft Lip and Nose Deformities in Repaired Unilateral Cleft Lip
Official title: Assessment of Secondary Cleft Lip and Nose Deformities in Patients With Repaired Unilateral Cleft Lip: A Proposal for a New Classification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Unilateral Cleft Lip With or Without Cleft Palate
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria: All Patients with unilateral cleft lip who had undergone primary cleft lip repair surgeries during their first year of life at Sohag University Hospital from January 2006 to December 2020.

Exclusion Criteria:

1. Patients with multiple cleft lip repair surgeries.
2. If the primary cleft lip surgery was performed after the first year of life.
3. Patients with no available photographs

Primary outcomes:
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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Dixon 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.
citation: Russell 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.