Outcomes of Furlow&Conventional Palatoplasty Procedures

描述(由申请人提供)： 这项临床试验计划拨款是为了设计一项多中心、多学科的前瞻性随机试验，以评估两种腭裂修复技术--Furlow Double-Z腭裂成形术(Double Z)和瓣内膜内成形术(IVV)--的结果。这项研究的具体目的是确定10-12个月大接受双Z或IVV腭裂成形术的儿童口鼻瘘发生的主要终点和腭咽闭合不全的发生率是否相同。裂隙类型和裂隙宽度也可能影响这些主要终点，在修复腭裂时将对腭部结构进行一系列特定的测量。次要终点将是确定口鼻瘘或腭咽闭合能力的发生是否由于两种腭裂修复技术中的任何一个结构参数的不同而不同。患者将从四个主要的转诊网站招募：莱利儿童医院、阿克伦儿童医疗中心、莫特儿童医院和堪萨斯城的儿童慈善医院。这项试验的总计划登记人数为三年内的300名唇裂患者。在手术前，将进行适当的筛查，以排除认知延迟、感觉神经性听力损失或神经肌肉疾病的患者。所有患有腭裂的非综合征患者，无论是否患有唇裂，都将被提供参与试验。听力测试将在整个研究过程中进行，以最大限度地减少听力损失对数据的影响。言语语言评估将在9个月大的时候进行，后续的言语语言评估将每隔6个月进行一次，直到36个月，此后每年进行一次，直到6岁，或直到建议进行二次手术治疗。此外，在为期48个月的访问中，一盘母带将被送往五名独立的言语语言病理学家进行盲法评估。将使用鼻腔测量管理进行腭咽闭合评估，并通过单独的数据中心进行分析。目前还没有公布的随机对照试验来比较这些双Z或IVV技术，而且，尽管这是第三种最常见的出生缺陷，但在裂隙研究中发表的随机试验很少。此外，还没有关于腭部结构参数及其对口鼻瘘和腭咽闭合能力的影响的研究发表。

DESCRIPTION (provided by applicant): This clinical trial planning grant is to design a multi-center, multi-disciplinary prospectively randomized trial to evaluate the outcomes following two cleft palate repair techniques--Furlow double-Z palatoplasty (Double Z) and intra-velar veloplasty (IVV). The specific aims of the study are to determine if the primary endpoints of the occurrence of oro-nasal fistulae and the rate of velopharyngeal insufficiently of children undergoing double Z or IVV palatoplasty at 10-12 months of age are the same. It is also believed that cleft type and cleft width may influence these primary endpoints, a series of specific measurements of palatal architecture will be made at the time of palatal repair. Secondary endpoints will be to determine if the occurrence of oro-nasal fistulae or velopharyngeal competence differs as a result of any of these architectural parameters in the two techniques of palatal repair. Patients will be recruited from four major referral sites: Riley Hospital for Children, Children's Medical Center of Akron, Mott Children's Hospital and Children's Mercy Hospital in Kansas City. Total planned enrollment in the trial is 300 cleft patients over three years. Prior to surgery, appropriate screens will be performed to exclude patients with cognitive delay, sensori-neuronal hearing loss, or neuromuscular disorders. All non-syndromic patients with cleft palate, with or without cleft lip, will be offered participation in the trial. Audiology testing will be performed throughout the study to minimize the influence of hearing loss upon the data. A speech-language assessment will be performed at nine months of age, and follow-up speech language assessments will be at six-month intervals until 36 months of age, and on an annual basis thereafter until six years of age, or until secondary surgical management is recommended. In addition, a master tape at the 48-month visit will be sent to five independent speech-language pathologists for evaluation in a blinded fashion. Velopharyngeal assessment will be made using nasometry management and analysis will be performed through a separate data center. There are no randomized controlled trials published that compare these techniques of double Z or IVV, and, furthermore, there have been very few randomized trials published in cleft studies, despite this being the third most common birth defect. In addition, there have been no studies on the palatal architecture parameters and their influence upon oronasal fistulae and velopharyngeal competence that have been published.