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）：出生的婴儿唇/cl裂（Cl/p）的婴儿具有明显的面部残疾。出生后不久，外科医生对嘴唇进行初始或初级修复。不幸的是，初始手术对面部软组织形式和/或运动的影响高度可变。许多患者对面部软组织运动的面部毁容和损害保持不满意，并且需要进行多次手术以改善初始结果。进行额外修订手术的决定是基于对外科医生对嘴唇和鼻子进行的主观评估（与患者/父母一起进行的）。我们已经开发了一组新型的静态和动态定量和客观方法和措施，以评估运动（损伤）和形式（毁容）的面部软组织结果。这些方法是在NIH Grants de 013814，DE 016964和DE 013813-08S1的主持下开发的。因此，此R34计划赠款应用的目的是为将来的随机临床试验奠定基础，以评估外科医生对动态和静态定量测量的使用是否可以通过仅使用当前的主观评估来改善超出患者的面部软组织外科手术结果。该计划赠款的具体目的如下。具体目的1。评估每个颅面中心的招聘潜力。具体目的2。完善（1）评估面部障碍 /毁容的方法和客观措施，以及Cl / p婴儿中的Oromotor语音技能的发展； （2）培训外科医生在使用客观度量方面的方案； （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），其中包括但不限于开发同意书的发展和同意形式，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，通过改善手术治疗的结果并限制了CL/P子女，父母和健康社区的重复手术干预措施的负担，可以通过改善手术治疗的结果来表现出对颅面护理的可持续影响。 公共卫生相关性：每年在美国大约有6,800个出生，估计有80％的人受到非综合性，零星的单侧或双侧裂口和/或pa的影响。尽管出生的单侧或双侧裂口唇裂和pa裂的儿童受到原发性嘴唇修复的受益，但由于不满或残留障碍 /毁容，大多数儿童将接受随后的唇部修订手术。在过去的十年中，包括负责CL/P儿童护理的外科医生在内的我们的调查团队开发了一种客观的定量评估方法，该方法结合了静态和动态运动。该计划赠款将为多中心两组平行的随机临床试验提供结构，以比较外科医生使用创新评估措施以及不进行的治疗结果。这项计划赠款是实现我们的总体目标的第一步，即改善具有单侧或双侧非综合症完全cle裂的孩子的结果。