Adjuvant Adenoidectomy Plus Tympanostomy Tube Placement for the Treatment of Chronic OME in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 380
- 主要终点
- Recurrence rate
研究概览
简要总结
This study aims to verify the efficacy of adjuvant adenoidectomy for children with chronic OME who become candidates for tympanostomy tube placement, and explore potential factors associated with the efficacy of adjuvant adenoidectomy.
详细描述
Otitis media with effusion is a common condition in children, and tympanostomy tube placement is the first-line treatment for those who requires surgical interventions. Adenoidectomy proves to be helpful to children over 4 years old, but the risks of adjuvant surgery is believed to somehow offset its benefits. This study is meant to verify if concurrent adenoidectomy provides extra benefits in resolving MEE, reducing AOM, and improving hearing and patients' quality of life to children who become candidates for TT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 4-12 years of age.
- •Diagnosed with chronic OME. Diagnostic criteria: I. Middle ear effusion detected by otoscopy; II. Type B or C tympanograms; III. Symptoms/signs of OME persisted for >3 months;
- •Documented hearing loss ≥20dB (average threshold of 500Hz, 1000Hz and 2kHz in pure tone audiometry).
- •Adenoid hypertrophy (A/N ratio> 0.5 in lateral radiography of the nasopharynx).
- •Informed consent given by the patients and their guardians.
排除标准
- •Cleft palate or other systemic disorders.
- •Patients are diagnosed with other nose, sinuses or ear diseases that are eligible for surgical treatment.
- •Patients are diagnosed with OSAHS, tonsil hypertrophy ≥II° or scheduled for tonsillectomy.
- •History of tympanostomy tube placement.
- •Infection of the upper respiratory tract or acute rhinosinusitis over the past 7 days.
- •Sensorineural hearing loss.
- •Other situations that the investigators find unsuitable for the trial.
结局指标
主要结局
Recurrence rate
时间窗: 1 year after tube removal
Rate of OME recurrence
Rate of repeated tube placement
时间窗: 1 year after tube removal
proportion of patients who need repeated tube insertion
次要结局
- AOM attacks(1 year after tube removal)
- Otorrhea(2 years after tube insertion)
- Pure tone audiometry(2 years after tube insertion)
- Otitis Media-6 and Pediatric Sleep Questionnaire(2 years after tube insertion)
- Complications(2 years after tube insertion)
- Costs of OME-related visits and treatment(Through study completion, an average of 2 years)