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.

我们建议进行一项为期5年的前瞻性、随机、盲法、对照研究，以评估比较疗效