Functional Outcomes of Cleft Lip Surgery

唇裂手术的功能结果

• 批准号: 8175153
• 负责人: CARROLL ANN TROTMAN
• 金额: $ 22.2万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8175153
• 关键词: Affect; Applications Grants; Behavior; Bilateral; Birth; Caring; Child; Cleaved cell; Cleft Lip; Cleft Palate; Clinical; Clinical Trials; Community Health; Congenital Abnormality; Consent Forms; Cost Measures; Development; Diagnosis; Economic Burden; Esthetics; Evaluation; Face; Family; Future; Goals; Grant; Impairment; Lead; Lip structure; Manuals; Measures; Medical; Methodology; Methods; Movement; Nose; Operative Surgical Procedures; Outcome; Palate; Parents; Participant; Patients; Phase; Population Study; Procedures; Protocols documentation; Randomized Clinical Trials; Repeat Surgery; Research; Residual state; Site; Speech; Staging; Structure; Surgeon; Time; Training; Treatment outcome; United States; United States National Institutes of Health; base; cleft lip and palate; cost; craniofacial; disability; experience; functional outcomes; improved; innovation; novel; orofacial; primary outcome; psychosocial; repaired; skills; soft tissue; stressor; treatment planning

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.

描述（由申请人提供）：出生时患有唇裂/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状和/或运动的影响变化很大。许多患者不满意，仍然存在面部毁容和面部软组织运动障碍，需要多次手术才能改善最初的结果。进行额外修复手术的决定是基于外科医生（与患者/父母一起）对嘴唇和鼻子的主观评估。我们开发了一套新颖的静态和动态定量和客观方法和措施来评估运动（损伤）和形态（毁容）的面部软组织结果。这些方法是在 NIH 拨款 DE 013814、DE 016964 和 DE 013813-08S1 的支持下开发的。因此，这项 R34 规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测量是否可以改善患者的面部软组织手术结果，超出使用动态和静态定量测量所取得的效果。仅当前主观评估。本次规划补助金的具体目标如下。具体目标 1. 评估每个颅面中心的招募潜力。具体目标 2. 完善 (1) 评估 CL/P 婴儿面部损伤/毁容和口部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测量的方案； (3) 用于研究人群的心理社会和成本测量。具体目标 3. 制定程序手册 (MOP)，其中包括但不限于制定同意书和同意书、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，定量评估的纳入将通过改善手术治疗的结果并限制 CL/P 儿童、其父母和卫生界重复手术干预的负担，对颅面护理产生明显的可持续影响。 公众健康相关性：在美国，口面部裂每年影响大约 6,800 名新生儿，估计 80% 的新生儿患有非综合征性、散发性单侧或双侧唇裂和/或腭裂。虽然出生时患有单侧或双侧唇腭裂的儿童可以从初次唇部修复中受益，但大多数儿童会因为不满意或残留损伤/毁容而接受后续的唇部修复手术。在过去的十年中，我们的研究团队（包括负责 CL/P 儿童护理的外科医生）开发了一种结合静态和动态运动的客观定量评估方法。该规划拨款将为多中心两组平行随机临床试验提供结构，以比较外科医生使用和不使用创新评估措施时的治疗结果。这项规划拨款代表了实现我们改善单侧或双侧非综合征性完全性唇腭裂儿童的预后这一总体目标的第一步。