Distribution of Bacteria in Otitis Media With Effusion After Radiotherapy For Nasopharyngeal Carcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Positive Bacterial Culture Rate in Middle Ear Effusion
研究概览
简要总结
To observe the prognostic difference of tympanocentesis in different kinds of otitis media effusion.
详细描述
This study is a prospective, observational clinical study to observe the difference in prognosis of tympanocentesis in different kinds of otitis media effusion (OME), especially OME after radiotherapy for nasopharyngeal carcinoma (NPC). A total of 234 patients diagnosed with OME who are given the treatment of tympanocentesis only, including outpatient and inpatient patients, were included in the study. The middle ear effusion collected during the tympanocentesis is sent for bacterial culture. The positive rate of the effusion and the recurrence rate within 24 weeks will be compared in order to figure out whether bacterial infection is an important influencing factor for some kinds of OME in addition to eustachian tube dysfunction, which is acknowledged.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients clinical diagnosis of OME or OME after radiotherapy for NPC (Diagnostic criteria: fluid visible in the middle ear and a type B tympanogram).
- •patients volunteered to participate in the study and signed the informed consent
排除标准
- •NPC recurrence or other malignant tumor after radiotherapy.
- •clear diagnosis of Eustachian ostium atresia or nasal obstruction diseases, such as severe deviated nasal septum, choanal atresia, osteoradionecrosis of skull base after radiotherapy, etc.
- •pregnant and lactating women.
- •patients with severe underlying diseases or with severe liver and kidney dysfunction.
- •patients who could not cooperate (including poor hearing and radiation encephalopathy)
- •patients with other middle ear diseases, such as middle ear cholesteatoma, osteoradionecrosis of temporal bone after radiotherapy, etc.
- •severe deglutition disorders
- •cleft palate
结局指标
主要结局
Positive Bacterial Culture Rate in Middle Ear Effusion
时间窗: Up to 24 weeks
次要结局
- Eustachian Tube Dysfunction Questionnaire (ETDQ-7)(Collected at 6, 12, 24 Weeks after Tympanocentesis)
- Changes in Air Pressure (Tympanogram)(Collected at 6, 12, 24 Weeks after Tympanocentesis)