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: 8898754
• 负责人: Cuneyt Metin Alper
• 金额: $ 50.73万
• 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 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8898754
• 关键词: 3 year old; 7 year old; Acute; Address; Adoption; Adverse event; Affect; Age; Age-Months; Algorithms; Bilateral; Blinded; Child; 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 cleft; 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 年的前瞻性、随机、盲法、对照研究来评估比较 两种腭成形术方法在改善咽鼓管功能（ETF）和减少咽鼓管功能方面的功效 腭裂（CP）患者中渗出性中耳炎（OME）和听力损失的患病率 引起不良事件或对受 CP 影响的其他功能产生有害影响。 评估的腭成形术是 Furlow 双对 Z 成形术，双侧腭张张量交易 腭肌 (mTVP) 肌腱 (FP) 以及该手术的改良方案，包括双侧张肌腱固定术 (MFP)，即在 mTVP 肌腱横断之前将 mTVP 肌腱附着到同侧的单侧股骨上。超过一个 在 4 年期间，我们将招募 120 名 6 个月大的非综合征性 CP 受试者，这些受试者被分类为 Veau I-IV。 手术程序将包括在 3-6 个月大时进行唇裂修复（如果有）、双侧植入 在 3-6 个月大时使用通气管 (VT)，在大约 9-11 个月大时进行指定的腭成形术，以及 根据基于中耳的算法，在腭成形术后重复双侧 VT 插入以研究结束 （我）状态。术后 ME 状态评估（耳镜检查、鼓室导抗测试）将定期进行 间隔和 3 年终点，包括 ETF 和听力测试。主要结果包括 ETF 以及那些达到以下目标的受试者在腭成形术后 OME 和听力损失的发生率和患病率 5年学习期结束时年满3岁。次要成果包括以下措施： 作为临床随访的一部分，对脑瘫儿童进行评估；即腭咽能力、言语发展 以及修复腭成形术的需要。我们比较这两种腭成形术手术，因为它们的预期 差异仅对 mTVP 功能产生影响。我们的预期是 ETF 会更好，并且 MFP 组的 OME 和听力损失较少，但次要结果指标不会有不同 3 年终点时 2 组之间的差异。在 12 个受试者/组中，ETF 的术中记录将被 在电刺激左 mTVP 和左提肌 Veli Palatini 肌 (mLVP) 之前和之前完成 然后在涉及操纵这些肌肉的程序的每个步骤之后。我们期望测试 不同手术步骤的结果将阐明这些肌肉在 CP 患者的 ETF 中发挥的作用。在一个 为了竞争更新此应用程序，我们计划对 7 岁以下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 120 的样本量是为了 7岁时辍学率为25%，因此保留了检验各种假设的统计能力。如果 事实证明，MFP 在 3 岁及以后的主要结局方面优于 FP，但事实并非如此。 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 为改变当前腭成形术的方式而争论的基础，并重新强调 减少 CP 病症的耳科并发症。