Cleft lip/palate (CL/P) are among the most common of all birth defects. To correct the obvious facial disabilities of babies with CL/P, surgeons perform an initial or primary repair of the lip and nose soon after birth. Unfortunately, many patients (and caregivers) are dissatisfied with the surgical results: Patients remain with a facial disfigurement and impairment in facial soft tissue movements-particularly in facial expressive behaviors. Multiple revision surgeries during childhood and adolescence are common to improve the initial results. The psychosocial and economic burden of care on these children and their caregivers are great. Traditionally, the decision for lip revision surgery has been based on subjective assessments of nasolabial form, and less frequently, circumoral movement but without a method to quantify the facial movements/form before surgery or after surgery. To this end, we have developed an Intervention that utilizes a novel set of dynamic and static quantitative measures and a systematic subjective evaluation to quantify facial disability for the treatment planning of lip surgery and for assessing surgical outcomes. The quantitative measures include (1) 3D dynamic and statistical modeling of patients' mean facial movements and (2) 3D static facial image data, both compared with mean control movement and static image data, respectively. As a necessary second step in this formative research, using separate prospective cohorts of patients who have lip revision and lip repair surgery, we will conduct a 'proof of concept' Phase II randomized clinical trial (RCT) with the following Specific Aims.
Specific Aim 1. To qualitatively assess how surgeons integrate the Intervention's objective measures and visual aids with the systematic subjective assessment in the decision-making process for the clinical surgical procedures of lip revision and lip repair.
Specific Aim 2. To quantitatively assess the extent to which the Intervention changes surgeons' problem list and treatment planning goals for lip revision and lip repair.
Specific Aim 3. To obtain estimates on means, variances, and intra-patient correlation, and to estimate surgeon-by-condition interaction effects for surgical outcomes under the Intervention and the standard of care or Control conditions. Ultimately, while this Phase II RCT is not a therapeutic trial in the usual sense of providing a patient with a therapy, it will be unique for craniofacial rehabilitation in that the fcus is to optimize the design of a novel assessment, improve an individual patient's diagnostic evidence base available to the surgeon for surgical planning, and evaluate whether post-surgical results are improved with the Intervention.
Orofacial clefts affect approximately 6,800 births in the United States each year with an estimated 80% affected with a non-syndromic, sporadic unilateral or bilateral cleft lip and/or palate (CL/P). Although these babies benefit from primary lip repair, wih age the majority will undergo subsequent lip revision surgeries due to dissatisfaction with the appearance of the form of the lip and nose, and residual impairments in lip function or movement. Our research team, which included surgeons experienced in the care of CL/P children, has developed a novel Intervention approach that utilizes objective dynamic and static measures/quantitative visual aids together with a systematic subjective evaluation to quantify facial disability for treatment planning for lip surgery and to assess surgical outcomes. Using thi Intervention, the goals of this Phase II randomized clinical trial are to determine how surgeons integrate the objective measures/ visual aids of the Intervention with their subjective assessment; to determine the extent to which the Intervention changes surgeon's treatment plan/goals for surgery; and to determine whether surgeons achieve their surgical goals. This trial represents a major step towards achieving our overall goal of improving the facial soft tissue outcomes for children born with unilateral or bilateral CL/P.
| Trotman, Carroll Ann; Faraway, Julian; Hadlock, Tessa et al. (2018) Quantifying Soft Tissue Shape and Symmetry: Patients with Cleft Lip/Palate and Facial Paralysis. Plast Reconstr Surg Glob Open 6:e1715 |
