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
基本信息
- 批准号:8234221
- 负责人:
- 金额:$ 24.35万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:3 year old7 year oldAcuteAddressAdoptionAdverse eventAffectAgeAge-MonthsAlgorithmsBilateralBlindedChildCleaved cellCleft LipCleft PalateCleft lip with or without cleft palateClinicalCompetenceControlled StudyDataDentalDropsElectric StimulationEnrollmentEnvironmental air flowEtiologyEustachian TubeEvaluationFaceFistulaFoundationsFunctional disorderFundingGoalsGrowthHearingHearing TestsIncidenceInfantIpsilateralLeftMeasuresMethodsModificationMuscleMuscle functionNoseOdontogenesisOperative Surgical ProceduresOralOtitis MediaOtitis Media with EffusionOtoscopyOutcomeOutcome MeasurePatientsPlayPositioning AttributePostoperative PeriodPrevalenceProceduresProcessQuality of lifeRandomizedRelative (related person)ReportingResearch SupportResolutionRoleSample SizeSpecific qualifier valueSpeechSpeech DevelopmentSurgeonTechniquesTendon structureTest ResultTestingTimeTubeTympanometryVelopharyngeal Insufficiencyadverse outcomebasecomparative efficacycraniofacialdesignexpectationfollow-uphearing impairmentimprovedmiddle earorofacialpalate repairprimary outcomeprospectiverepairedsecondary outcomevector
项目摘要
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(申请人提供):我们提出了一项为期5年的前瞻性、随机、盲法,对照研究,评估2种腭成形术方法在改善耳咽管功能(ETF)、降低分泌性中耳炎(OME)和腭裂(CP)听力损失患病率方面的比较功效患者不会引起不良事件或对受CP影响的其他功能产生有害影响。评价的腭成形术是Furlow双反向Z成形术,双侧腭帆张肌(mTVP)肌腱(FP)和该手术的改良,包括双侧张肌肌腱固定术(MFP),即在mTVP肌腱横断前将mTVP肌腱连接到同侧钩。在4年的时间内,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。手术程序将包括在3-6月龄时进行唇裂修复(如果存在),在3-6月龄时双侧放置通气管(VT),在约9-11月龄时进行指定的腭裂修复术,并根据基于中耳(ME)状态的算法,在腭裂修复术后重复双侧VT插入,直至研究结束。将定期和在3年终点时对ME状态(耳镜检查、鼓室压测定)进行术后评估,包括ETF和听力测试。主要结局包括在5年研究期结束时年龄达到3岁的受试者的ETF以及腭裂术后OME和听力损失的发生率和患病率。次要结局包括作为临床随访的一部分在CP儿童中评估的指标;即,咽功能、言语发育和腭裂修复术的需要。我们比较了这两种腭裂手术,因为它们预期仅对mTVP功能有不同影响。我们的预期是ETF将更好,MFP组中OME和听力损失的患病率更低,但在3年终点时,两组之间的次要结局指标没有差异。在12名受试者/组中,将在涉及操纵这些肌肉的程序中的每个步骤之前和之后,在左mTVP和左腭帆提肌(mLVP)的电刺激期间进行ETF的术中记录。我们希望在不同的程序步骤的测试结果将澄清在ETF中发挥的作用,这些肌肉在CP患者。在本申请的竞争性更新中,我们计划对所有入组的受试者进行相似的评估,直至7岁,并在4岁、5岁、6岁和7岁时进行额外的结局评价。我们选择的样本量为120例,以允许7岁时有25%的脱落率,从而保留检验各种假设的统计学把握度。如果MFP被证明在3岁及以后的主要结局方面优于FP,并且与不良事件或对其他功能的不良影响无关,则这些结果将为改变当前腭成形术的方式提供依据,并重新强调减少CP条件的耳科并发症。
公共卫生相关性:CP婴儿的OM和听力损失的患病率接近100%,在标准的腭裂修复术后没有降低,并且在所有年龄段都大于非CP患者。这项前瞻性、盲法、随机研究比较了更标准的Furlow腭裂修复术与该技术的改良Furlow腭裂修复术联合张肌固定术的疗效,后者旨在改善ETF,从而促进这些患者OM和听力损失的早期解决。如果改良Furlow腭成形术在改善ETF、ME状态和听力方面上级标准Furlow腭成形术,而不会对CP影响的其他功能造成不良后果,则预计应用该改良手术可改善CP患者的生活质量,并将CP外科医生的重点重新定位为改善这些患者的耳科结局。
项目成果
期刊论文数量(0)
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Cuneyt Metin Alper其他文献
Cuneyt Metin Alper的其他文献
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{{ truncateString('Cuneyt Metin Alper', 18)}}的其他基金
Balloon Dilation in Selected Subjects with Refractory Eustachian Tube Dysfunction
患有难治性咽鼓管功能障碍的特定受试者的球囊扩张
- 批准号:
8634381 - 财政年份:2014
- 资助金额:
$ 24.35万 - 项目类别:
Balloon Dilation in Selected Subjects with Refractory Eustachian Tube Dysfunction
患有难治性咽鼓管功能障碍的特定受试者的球囊扩张
- 批准号:
8828666 - 财政年份:2014
- 资助金额:
$ 24.35万 - 项目类别:
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 - 财政年份:2011
- 资助金额:
$ 24.35万 - 项目类别:
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:
8703656 - 财政年份:2011
- 资助金额:
$ 24.35万 - 项目类别:
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 - 财政年份:2011
- 资助金额:
$ 24.35万 - 项目类别:
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:
8336865 - 财政年份:2011
- 资助金额:
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- 批准号:
6576304 - 财政年份:2002
- 资助金额:
$ 24.35万 - 项目类别:
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