ADENOIDECTOMY FOR OTITIS MEDIA IN 2/3 YEAR OLD CHILDREN

2/3 岁儿童中耳炎的腺切除术

• 批准号: 2654425
• 负责人: Margaretha Linnea Casselbrant
• 金额: $ 39.94万
• 依托单位: CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-01 至 2002-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2654425
• 关键词: adenoidectomy; clinical research; conductive hearing loss; drug resistance; exudate /transudate; human subject; human therapy evaluation; otitis media; preschool child (1-5); tympanoplasty

DESCRIPTION: Efficacy of adenoidectomy for the treatment and prevention of otitis media with effusion has been shown for children four years and older. In their "Clinical Practice Guidelines, Otitis Media with Effusion in Young Children", the Agency for Health Care Policy and Research of the U.S. Department of Health and Human Services concluded that "Adenoidectomy is not recommended for treatment of OME in a child age 1 through 3 years in the absence of specific adenoid pathology". This conclusion was based on the Panel's finding no clinical trials to support any judgement as to the efficacy of adenoidectomy in the primary management of otitis media with effusion in very young children, coupled with the risk of postoperative bleeding. By means of a well designed large-scale randomized controlled trial, the efficacy of adenoidectomy and myringotomy with and without tympanotomy tube insertion will be compared with that of myringotomy and tympanotomy alone in reducing the morbidity of bilateral otitis media with effusion of at least 3 months's duration associated with hearing loss (>20 dB) in children ages 2 and 3 years. The primary outcome measure will be percentage of time with middle ear effusion. Rates of episodes of acute otitis media, otorrhea, and otitis media with effusion, time to first recurrence, number of surgical procedures, treatment failures, hearing status, and other sequelae and complications will be recorded and compared among the three treatment groups. We estimate that 63 evaluable subjects need to be entered in each treatment arm to have a 90 percent power of detecting a benefit of at least 0.30 in percentage of time with middle ear effusion. The outcome of this trial should resolve the question of efficacy of adenoidectomy for otitis media with effusion in this age group.

描述：腺样体切除术治疗和预防 四岁以上的儿童患有渗出性中耳炎。 在他们的“临床实践指南”中， 儿童”，美国卫生保健政策和研究机构。 卫生与公众服务部得出结论，“腺样体切除术不是 推荐用于治疗1至3岁儿童的OME， 没有特定的腺样体病理学”。 这一结论是基于 专家组没有发现任何临床试验来支持关于 腺样体切除术在原发性中耳炎治疗中的疗效 在非常年幼的儿童，再加上术后的风险 流血了 通过一项设计良好的大规模随机对照试验， 腺样体切除术联合鼓膜切开置管与不置管疗效比较 插入将与鼓膜切开术和单纯鼓膜切开术进行比较， 降低渗出液至少为3的双侧中耳炎的发病率， 与2岁儿童听力损失（>20 dB）相关的持续时间 3年。 主要结局指标将是发生以下情况的时间百分比： 中耳积液 急性中耳炎、中耳炎和 渗出性中耳炎，首次复发时间，手术次数 手术、治疗失败、听力状况和其他后遗症， 比较三种治疗方法的并发症 组 我们估计，每项研究需要63名可评价的受试者 治疗组有90%的把握度检测至少 0.30中耳积液时间百分比。 这场 试验应解决腺样体切除术治疗中耳炎的有效性问题 在这个年龄组中有积液。