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: 8234221
• 负责人: Cuneyt Metin Alper
• 金额: $ 24.35万
• 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/8234221
• 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

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: The prevalence of OM and hearing loss in CP infants approaches 100%, does not decrease after standard methods of palatoplasty and is greater than that for than that for non-CP patients at all ages. This prospective, blinded, randomized study compares the efficacies of the more standard Furlow palatoplasty with a modification of that technique, Furlow palatoplasty with tensor tenopexy, which was designed to improve ETF and, consequently, promote the earlier resolution of OM and hearing loss in those patients. If the modified Furlow palatoplasty is shown to be superior to the standard Furlow palatoplasty with respect to improving ETF, ME status and hearing without adverse consequences on the other functions affected by the presence of a CP, application of this revised procedure is expected to improve the quality of life in CP patients and redirect the focus of CP surgeons to improve the otologic outcomes in these patients.

描述（由申请人提供）：我们提出了一项为期5年，前瞻性，随机，失明，对照研究的研究，以评估两种对改善Eustachian Tube功能（ETF）的palatoptuse方法的比较效率（ETF），并降低因果（OME）而不受cle虫（OME）的影响（CP）患者（CP）的影响（cp）患者的患者的流行，并降低了造成的（cp）的影响（cp）。 CP的存在。 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.在4年的时间内，我们将在6个月的6个月内注册120名非综合性CP受试者。手术程序将包括3-6个月大的唇裂修复（如果存在），在3-6个月大的年龄在3-6个月大的时候将通风管（VT）放置在大约9-11个月大的年龄时指定的palatoplasty，并重复双侧VT插入后，以对山地的状态进行研究，以研究止痛药的状态（MED（MIDER）。 ME状态的术后评估（耳镜，鼓膜计）将定期进行，并在3年​​终点，包括ETF和听力测试。对于那些在5年研究期结束之前，达到3岁的受试者，主要结果包括ETF和OME的发病率和出现率和听力损失。次要结果包括在CP儿童中评估的措施，作为其临床随访的一部分；即尾咽能力，言语发展和对修订palatoplasty的需求。我们比较了这两种palatoplasty程序，因为它们仅对MTVP功能具有预期的差异作用。我们的期望是，ETF会更好，MFP组的OME和听力损失的率会更好，但是在3年终点，两组之间的次要结果指标将不会有所不同。在12个受试者/组中，在对左MTVP的电刺激和左Levator Veli Palatini肌肉（MLVP）的电刺激期间，将进行ETF的术中记录，然后在涉及操纵这些肌肉的过程中的每个步骤之前和之后进行。我们预计在不同的程序步骤下的测试结果将阐明这些肌肉在CP患者中在ETF中起作用的作用。在对本申请的竞争续约中，我们计划对所有注册受试者进行类似的评估，包括7岁的所有受试者，并在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％，因此可以保留统计能力以测试各种假设。如果在3岁及以后的几年中，MFP比FP更好，并且与不良事件或对其他功能的不良影响无关，那么这些结果将为改变当前的palapoplasties的方式提供基础。 公共卫生相关性：CP婴儿的OM和听力损失的患病率100％接近，在标准的Palatoplasty方法之后不会降低，并且比所有年龄段的非CP患者的患病率都大于降低。这项前瞻性，盲目的随机研究比较了更标准的Furlow palatophats成形术的功效与对该技术的修改，Furlow Palatopplasty和Tensor Tenopexy的效果，该技术旨在改善ETF，因此促进了这些患者对OM的早期分辨率和听力损失。 If the modified Furlow palatoplasty is shown to be superior to the standard Furlow palatoplasty with respect to improving ETF, ME status and hearing without adverse consequences on the other functions affected by the presence of a CP, application of this revised procedure is expected to improve the quality of life in CP patients and redirect the focus of CP surgeons to improve the otologic outcomes in these patients.