Functional Outcomes of Cleft Lip Surgery

描述（由申请人提供）：出生时唇裂/腭裂（CL/P）的婴儿有明显的面部残疾。出生后不久，外科医生会对嘴唇和鼻子进行初步或初步修复。不幸的是，初始手术对面部软组织形态和/或运动的影响是高度可变的。许多患者不满意并保留面部畸形和面部软组织运动障碍，并需要多次手术来改善初步结果。外科医生（与患者/父母一起）对嘴唇和鼻子进行主观评估后，决定是否进行额外的修复手术。我们开发了一套新的静态和动态定量和客观的方法和措施来评估面部软组织运动（损伤）和形态（毁容）的结果。这些方法是在NIH资助DE 013814， DE 016964和DE 013813-08S1的支持下开发的。因此，本R34计划拨款申请的目标是为未来的随机临床试验奠定基础，以评估外科医生使用动态和静态定量措施是否能改善患者的面部软组织手术结果，而不仅仅是使用目前的主观评估。此规划奖助金的具体目的如下。具体目标评估颅面各中心的再募集潜力。具体目标2。完善(1)评估CL/P患儿面部损伤/毁容及运动言语技能发展的方法和客观措施；(2)培训外科医生使用客观措施的方案；(3)在研究人群中使用的社会心理和成本措施。具体目标3。制定程序手册（MOP），包括但不限于，制定同意书、外科医生和研究人员的培训材料和计划，以及现场质量管理计划。我们预计，定量评估的结合将通过改善手术治疗的结果和限制CL/P儿童、其父母和卫生社区重复手术干预的负担，对颅面护理产生可持续性的影响。

DESCRIPTION (provided by applicant): Babies born with a cleft of the lip/cleft palate (CL/P) have an obvious facial disability. Surgeons perform an initial or primary repair of the lip and nose soon after birth. Unfortunately, the effects of the initial surgeries on the facial soft tissue form and/or movement are highly variable. Many patients are dissatisfied and remain with a facial disfigurement and impairment in facial soft tissue movements, and require multiple surgeries to improve the initial results. The decision to perform additional revision surgeries is based on a subjective assessment of the lips and nose made by the surgeon (in conjunction with the patient/parents). We have developed a novel set of static and dynamic quantitative and objective methods and measures to assess the facial soft tissue outcomes of movement (impairment) and form (disfigurement). These approaches were developed under the auspices of NIH grants DE 013814, DE 016964, and DE 013813-08S1. Thus, the goal of this R34 planning grant application is to set the stage for a future randomized clinical trial to evaluate whether the use of the dynamic and static quantitative measures by surgeons improves the facial soft tissue surgical outcomes of patients beyond that achieved by using the current subjective assessments only. The Specific Aims of this planning grant are as follows. Specific Aim 1. To assess the recruitment potential of each craniofacial center. Specific Aim 2. To refine (1) the methodology and objective measures to assess facial impairment / disfigurement and the development of oromotor speech skills in babies with CL/P; (2) the protocol for training surgeons in the use of the objective measure; and (3) the psychosocial and cost measures for use in the study population. Specific Aim 3. To develop a Manual of Procedures (MOP), that will include, but is not limited to, the development of consent form(s) and assent form(s), training materials and plans for surgeons and study staff, and a site quality management plan. We anticipate that the incorporation of the quantitative assessments will have a demonstrated sustainable impact on craniofacial care by improving the outcomes of surgical treatment and limiting the burden of repeated surgical interventions in CL/P children, their parents, and the health community. PUBLIC HEALTH RELEVANCE: 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. Although children born with unilateral or bilateral cleft lip and palate benefit from primary lip repair, the majority of children will undergo subsequent lip revision surgeries because of dissatisfaction or residual impairment / disfigurement. During the past decade, our investigative team including surgeons responsible for the care of CL/P children have developed an objective quantitative assessment method that incorporates static and dynamic movements. This planning grant will provide the structure for a multi-center two-group parallel randomized clinical trial to compare the outcomes of treatment when surgeons use the innovative assessment measures and when they do not. This planning grant represents the first step in achieving our overall goal of improving the outcomes for a child born with a unilateral or bilateral non- syndromic complete cleft lip and palate.