ADENOIDECTOMY FOR OTITIS MEDIA IN 2/3 YEAR OLD CHILDREN

描述：腺样体切除术的疗效和预防 渗出性中耳炎多见于四岁及以上儿童。 在他们的《临床实践指南》中，青少年渗出性中耳炎 儿童“，美国卫生保健政策和研究机构。 卫生与公众服务部的结论是：“腺样体切除术并不是 推荐用于1至3岁儿童的OME治疗 没有特异腺样体病理“。这一结论是基于 专家小组没有发现任何临床试验来支持关于 腺样体切除术治疗中耳炎的疗效观察 幼儿的积液，再加上术后的风险 在流血。 通过精心设计的大规模随机对照试验， 鼓室置管腺样体切除和鼓膜切开术的疗效比较 将鼓膜切开术和鼓膜切开术与鼓膜切开术进行比较 减少积液3分以上的双侧中耳炎的发病率 与2岁儿童听力损失(&gt；20分贝)相关的几个月持续时间 三年。主要结果衡量标准将是 中耳积液。急性中耳炎、耳漏和 渗出性中耳炎、首次复发时间、手术次数 程序、治疗失败、听力状况和其他后遗症 并发症将被记录下来并在三种治疗方法中进行比较 组。我们估计，每一项都需要输入63个可评估的主题 治疗臂具有90%的检测至少有益于 出现中耳积液的时间百分比为0.30。这样做的结果是 试验应解决腺样体切除术治疗中耳炎的疗效问题 这个年龄段的渗出性中介物。

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.