Furlow Palatoplasty with Tensor Tenopexy for Otitis Media

沟腭成形术与张肌腱固定术治疗中耳炎

• 批准号: 8508240
• 负责人: Cuneyt Metin Alper
• 金额: $ 34.02万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-21 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8508240
• 关键词: 3 year old; 7 year old; Acute; Address; Adoption; Adverse event; Affect; Age; Age-Months; Algorithms; Bilateral; Blinded; Child; Cleaved cell; Cleft Lip; Cleft Palate; Cleft lip with or without cleft palate; Clinical; Competence; Controlled Study; Data; Dental; Drops; Electric Stimulation; Enrollment; Environmental air flow; Etiology; Eustachian Tube; Evaluation; Face; Fistula; Foundations; Functional disorder; Funding; Goals; Growth; Hearing; Hearing Tests; Incidence; Infant; Ipsilateral; Left; Measures; Methods; Modification; Muscle; Muscle function; Nose; Odontogenesis; Operative Surgical Procedures; Oral; Otitis Media; Otitis Media with Effusion; Otoscopy; Outcome; Outcome Measure; Patients; Play; Positioning Attribute; Postoperative Period; Prevalence; Procedures; Process; Quality of life; Randomized; Relative (related person); Reporting; Research Support; Resolution; Role; Sample Size; Specific qualifier value; Speech; Speech Development; Surgeon; Techniques; Tendon structure; Test Result; Testing; Time; Tube; Tympanometry; Velopharyngeal Insufficiency; adverse outcome; base; comparative efficacy; craniofacial; design; expectation; follow-up; hearing impairment; improved; middle ear; orofacial; palate repair; primary outcome; prospective; repaired; secondary outcome; vector

We propose a 5-year, prospective, randomized, blinded, controlled study that evaluates the comparative efficacies of 2 methods of palatoplasty with respect to improving Eustachian tube function (ETF) and reducing the prevalences of otitis media with effusion (OME) and hearing loss in cleft palate (CP) patients without causing adverse events or having detrimental effects on the other functions affected by the presence of a CP. The palatoplasties evaluated are the Furlow double opposing Z plasty with bilateral transaction of the tensor veli palatini muscle (mTVP) tendon (FP) and a modification of that procedure that includes bilateral tensor tenopexy (MFP), i.e. the attachment of mTVP tendons to the ipsilateral hamulus before mTVP tendon transection. Over a 4 year period, we will enroll 120 non-syndromic CP subjects by age 6 months who are classified as Veau I-IV. The surgical procedures will include cleft lip repair (if present) at 3-6 months of age, bilateral placement of a ventilation tube (VT) at 3-6 months of age, the designated palatoplasty at approximately 9-11 months of age and repeat bilateral VT insertions post-palatoplasty to study end as dictated by an algorithm based on middle ear (ME) status. Post-operative assessment of the ME status (otoscopy, tympanometry) will be done at regular intervals and at the 3-year endpoint with inclusion of ETF and hearing tests. Primary outcomes include ETF and the incidences and prevalences of OME and hearing loss after palatoplasty for those subjects who achieve the age of 3 years by the end of the 5 year study period. Secondary outcomes include measures that are assessed in CP children as part of their clinical follow-up; i.e. velopharyngeal competence, speech development and the need for revision palatoplasty. We compare these 2 palatoplasty procedures because of their expected differential effects only on mTVP function. Our expectations are that ETF will be better and the prevalences of OME and hearing loss less in the MFP group, but that the secondary outcome measures will not be different between the 2 groups at the 3 year endpoint. In 12 subjects/group, intra-operative recordings of ETF will be done during electrical stimulation of the left mTVP and left Levator Veli Palatini muscle (mLVP) before and then after each step in the procedures that involve manipulation of those muscles. We expect that the test results at different procedural steps will clarify the role played in ETF by these muscles in CP patients. In a competing renewal of this application, we plan to include similar assessments on all enrolled subjects to age 7 with additional outcome evaluations at age 4, 5, 6 and 7 years. Our sample size of 120 was chosen to allow for a drop-out of 25% by 7 years of age and, thus, to retain statistical power to test the various hypotheses. If the MFP proves to be better than the FP with respect to the primary outcomes at age 3 and later years and is not associated with adverse events or untoward effects on the other functions, these results will provide a foundation to argue for changing the way that current palatoplasties are done with a renewed emphasis on reducing the otologic complications of the CP condition.

我们提出了一项为期5年，前瞻性，随机，盲目对照的研究，以评估比较 两种方法对改善尤斯塔克式管功能（ETF）和还原的效力 没有积液（OME）的中耳炎和没有听力的患者（CP）患者的患病率 引起不良事件或对受CP影响影响的其他功能产生不利影响。 评估的palatoplasties是fuflow double z plasty tensor veli的双边交易 Palatini肌肉（MTVP）肌腱（FP）和该过程的修改，包括双侧张量 （MFP），即MTVP肌腱在MTVP肌腱横断之前的附着。在一个 4年期，我们将在6个月的年龄授予120名非综合性CP受试者，这些受试者被分类为Veau I-IV。 手术程序将包括3-6个月大的唇唇修复（如果存在），双边放置 3-6个月大的通风管（VT），大约9-11个月大的指定层状成形术 重复双侧VT插入后成形术后研究结束，如中耳中的算法所决定 （我）状态。 ME状态的术后评估（耳镜，鼓膜法）将在常规上进行 间隔和3年终点，包括ETF和听力测试。主要结果包括ETF 以及那些实现的受试者的OME的发病率和呼吸损失和听力损失 在5年学习期结束之前3岁。次要结果包括 作为临床随访的一部分，在CP儿童中评估；即尾咽能力，语音发展 以及对修订后置换术的需求。我们比较了这两个ala骨成形术程序，因为它们的预期 仅对MTVP函数的差异影响。我们的期望是ETF会更好，并且 MFP组的OME和听力损失较少，但是次要结果指标不会有所不同 在3年末点的两个组之间。在12个受试者/组中，ETF的术中记录将是 在对左MTVP和左左旋武器Veli Palatini肌肉（MLVP）的电刺激期间完成 然后，在涉及操纵这些肌肉的过程中的每一步之后。我们期望测试 在不同的程序步骤下的结果将阐明这些肌肉在CP患者中的ETF中所起的作用。在 对本申请的续约竞争，我们计划对7岁的所有注册受试者进行类似的评估 在4、5、6和7岁时进行额外的结果评估。我们选择了120个样本量以允许 到7岁时辍学25％，因此保留统计能力以检验各种假设。如果是 在3岁及以后的几年中，MFP被证明比FP更好，而不是 与不良事件或对其他功能的不良影响相关，这些结果将提供一个 主张改变当前的palapoplasties的方式，并重新强调 减少CP条件的耳科并发症。