Furlow Palatoplasty with Tensor Tenopexy for Otitis Media

我们提出了一项为期5年的前瞻性、随机、盲法、对照研究， 比较两种腭裂修复术方法在改善咽鼓管功能和降低腭咽闭合率方面的疗效 腭裂（CP）患者中分泌性中耳炎（OME）和听力损失的患病率， 导致不良事件或对受CP存在影响的其他功能产生有害影响。 评价的腭裂修复术是Furlow双反向Z形修复术， 腭肌（mTVP）肌腱（FP）以及包括双侧张肌腱固定术在内的改良手术 (MFP)即在mTVP肌腱横断前将mTVP肌腱附着于同侧钩。通过 4年期间，我们将入组120例年龄6个月的非综合征CP受试者，这些受试者被分类为Veau I-IV。 手术程序将包括唇裂修复（如果存在）在3-6个月的年龄，双边放置一个 在3-6个月大时进行通气管（VT），在大约9-11个月大时进行指定的腭裂修复术， 根据基于中耳的算法，在腭裂术后重复双侧VT插入，直至研究结束 (ME)status.将定期进行ME状态的术后评估（耳镜检查、鼓室检查） 间隔和3年终点，包括ETF和听力测试。主要成果包括ETF 以及腭裂术后OME和听力损失的发生率和患病率， 在5年研究期结束时年满3岁。次要结果包括以下指标： 作为临床随访的一部分，在CP儿童中进行评估;即，咽功能、言语发育 以及腭裂修复术的需要我们比较这2个腭裂手术，因为他们的预期 仅对mTVP功能产生差异效应。我们的预期是ETF会更好， MFP组的OME和听力损失较少，但次要结局指标不会有差异 3年终点时两组之间的差异。在12名受试者/组中，将记录ETF的术中记录。 在电刺激左mTVP和左腭帆提肌（mLVP）之前进行， 然后在涉及这些肌肉操作的程序的每一步之后。我们希望测试 不同手术步骤的结果将阐明CP患者中这些肌肉在ETF中所起的作用。中 竞争性更新本申请，我们计划对所有入组的受试者进行类似的评估，直至7岁 在4岁、5岁、6岁和7岁时进行额外的结果评估。我们的样本量为120， 到7岁时辍学率为25%，因此，保留统计能力来检验各种假设。如果 在3岁及以后的主要结局方面，MFP被证明优于FP， 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 基金会主张改变目前的腭裂修复术的方式，重新强调 减少CP病症的耳科并发症。

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.