Functional Outcomes of Cleft Lip Surgery

唇裂手术的功能结果

基本信息

批准号：
7747972
负责人：
CARROLL ANN TROTMAN
金额：
$ 60.35万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2001
资助国家：
美国
起止时间：
2001-05-01 至 2012-12-31
项目状态：
已结题

项目摘要

Primary surgical repair of a cleft lip has significant potential for scarring and disfigurement of the upper lip and nose that requires further correction. Patients, their parents, and the operating surgeons must decide whether the benefits of a secondary lip revision following primary correction of a cleft lip outweigh the risks. Until recently, quantitative data on the benefits of revision surgery have been lacking, and the clinical recommendations for or against revision surgery have necessarily been based on subjective and, therefore, variable evaluations. In the initial grant period, a non-randomized clinical trial was conducted that resulted in significant progress towards the development and characterization of objective quantitative outcomes of revision surgery in patients with cleft lip and palate. The database so established is now the only one in the world that has extensive objective measures of three-dimensional facial soft-tissue movement and morphology, lip force, lip sensation, and sensory-integrative function. The investigations proposed here represent an expansion of this research. Thus, the goals of this continuing project are as follows. 1) To determine how surgeons might use the newly-developed objective measures of lip function in the decision-making process for or against lip revision surgery. 2) To establish "parameters of care" criteria for secondary lip revision treatment based on standardized, systematic subjective evaluations, and objective measurements. 3) To investigate the long- term functional outcomes of lip revision surgery. This information will be obtained by continuing the present clinical trial and by enrolling an additional cohort of 30 new patients who will receive lip revision surgery. The central hypothesis continues to be that "although contemporary lip revision surgery may improve lip form at rest, function may be further impaired". This research will enable surgeons to address the following outcomes, and in doing so provide improved patient care: 1) measure the specific functional deficits that are present post-primary lip repair; 2) assess the effectiveness of current primary and secondary lip operations; 3) assess the long-term effects of lip repair on the maintenance of the circumoral milieu; 4) determine whether secondary lip surgery results in significant improvement in lip form and function; and 5) determine whether additional surgery is really warranted. In the future, these evaluations can be used to determine the outcomes of different surgical techniques forlip- revision surgery.

唇裂的原发性手术修复具有疤痕和毁容上唇的显着潜力和鼻子需要进一步校正。病人，他们的父母和手术外科医生必须决定主要纠正唇裂后，次级唇部修订的益处是否超过了风险。直到最近，还缺乏有关修订手术益处的定量数据，临床关于或反对修订手术的建议一定是基于主观的，因此可变评估。在最初的赠款期间，进行了非随机临床试验，导致朝着开发和表征客观定量结果的重大进展唇裂和口感患者的翻修手术。如此建立的数据库现在是具有三维面部软组织运动的广泛客观衡量的世界和形态，唇部力，唇部感和感觉融合功能。这里提出的调查代表这项研究的扩展。因此，这个持续项目的目标如下。 1）确定外科医生如何使用在决策过程中，新发达的唇部功能的客观措施用于唇部修订或反对唇部修订外科手术。 2）基于标准化，系统的主观评估和客观测量。 3）调查长期唇部修订手术的术语功能结果。这些信息将通过继续当前来获得临床试验，并招募30名将接受唇部修订手术的新患者组成的队列。这中心假设继续是：“尽管当代唇部修订手术可能会改善唇形的形式休息，功能可能会进一步损害”。这项研究将使外科医生能够解决以下结果，并提供改进患者护理：1）测量目前主要的唇部修复的特定功能缺陷； 2）评估当前主要和次级唇部操作的有效性； 3）评估唇部修复对的长期影响维护周围环境； 4）确定次级唇部手术是否导致显着唇形和功能的改善； 5）确定是否确实需要进行其他手术。在未来，这些评估可用于确定不同手术技术的结果。翻新手术。