Cicatrix, Cleft Lip and Palate, Growth and Development, Randomized Controlled Trial
Conditions
Keywords
Reconstructive surgical procedures, Therapy, soft tissue, Treatment outcome, Outcome Assessment (Health Care), Photogrammetry, Physical Appearance, Body
Brief summary
The aim of the study is to analyze the esthetic outcome of the first surgical repair of cleft lip and palate (CLP) patients. The aim of the study is to identify differences in the aesthetic evaluation of full-face and nasolabial region 3-D images of CLP patients following primary lip repair by laypeople.
Detailed description
The management of cleft lip and palate patient's generally involves the soft palate reconstruction as well as the repair of lip and nasal soft tissue defects. From an esthetic point of view, the primary repair, usually performed between 9 and 18 months of age, prepares the patients to grow into childhood and succeed in life without focusing on their deformity. An increasing number of outcome measure rating systems has been raised, suggesting a lack of consensus to a reliable, validated and reproducible scoring system for facial aesthetics in cleft patients. Many templates and lay panel scoring systems have been described, yet never fully validated. Advanced 3D imaging technologies may produce validated outcome measures in the future, but presently there remains a need to develop a robust method of facial aesthetic evaluation based on standardised patient photographs. The aim of the study is to to determine and compare the level of agreement among examiners' subjective aesthetic evaluation of full-face and nasolabial region 3-D images of CLP patients following primary lip repair by laypeople, developing some recommendations for a consistent scoring protocol.
Interventions
OTHERVAS scale (from 1 to 10) esthetic assessment of facial 3-D images
The rating process is biphasic: firstly a 3-D model is showed to the raters, who can orientate the vultus, familiarize with the 3-D technology and have a first glance evaluation. Secondly, the judges are asked to rate each of the following patient views: right profile, left profile, frontal, neck hyperextension and hyperflexion views Two weeks after the first assessment, the same judges assessed the same number of pictures, once again in random order.
Sponsors
Prof. Massimo Cordaro
Dr. Romeo Patini
Dr. Oliva Giorgio
Dr. Candida Ettore
Dr. De Luca Marilisa
Dr. Rizzo Maria Ida
Dr. Zama Mario
Dr. Rajabtork Zadeh Oriana
Dr. Bucci Daria
Prof. Gallenzi Patrizia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* age, between 20 and 25 years * sex, in order to have at least 25 male and female raters * sociocultural status: the layperson panel includes undergraduate students without extensive professional knowledge on cleft lip and palate patients
Exclusion criteria
* previous participation in research studies * familiarity or close friendship with cleft lip and palate patients * lack of blindness about the study protocol (it could bias the reported results)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrarater and interrater consistency | 3-D images are assessed twice, the timespan between the two evaluations is two weeks | The primary outcome of this study is to compare intrarater and interrater reliability of the ratings in both groups. The reliability of a panel of 3 and 6 judges for the different scoreswere estimated by using the Cronbach alfa formula. |
Countries
Italy
Outcome results
None listed