A Proposal for a New Classification of Secondary Cleft Lip and Nose Deformities in Repaired Unilateral Cleft Lip

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.

Study Overview

• Status: Completed
• Conditions: Patients With Unilateral Cleft Lip With or Without Cleft Palate
• Intervention / Treatment: Other: Patients with Unilateral Cleft Lip with or without Cleft Palate

• Study Type: Observational
• Enrollment (Actual): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Unilateral Cleft Lip with or without Cleft Palate	Other: Patients with Unilateral Cleft Lip with or without Cleft Palate; 2 dimensional Photographs of patients with unilateral cleft lip with or without cleft palate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate; Cleft Lip
• Other Study ID Numbers: Soh-Med-21-07-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No