The Therapeutic Effect of Balloon Eustachian Tuboplasty (BET) in Chronic Otitis Media (COM) With Eustachian Tube Dysfunction (ETD)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recurrence rate in chronic otitis media with eustachian tube dysfunction
研究概览
简要总结
Currently, surgical treatment of patients with chronic otitis media is one of the most important treatment methods. However, the current results show that some patients with eustachian tube dysfunction can't reconstruct the gas-containing structure of the middle ear after operation.
This is a randomized controlled trial that aims to evaluate the therapeutic effect of balloon eustachian tuboplasty (BET) for the treatment in chronic otitis media (COM) with eustachian tube dysfunction (ETD). This future study will aim to address the question: Does BET gain better recovery of auditory function and lower recurrence rate in chronic otitis media with eustachian tube dysfunction?
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who need tympanoplasty, with clear diagnosis of chronic otitis media, middle ear cholesteatoma;
- •Patients with eustachian tube dysfunction using TMM;
- •Subjects or their legal representatives can understand the purpose of the study, show sufficient compliance with the research protocol, and sign the informed consent form.
排除标准
- •Secondary chronic otitis media (after head and neck cancer radiotherapy);
- •Ipsilateral ear recurrence after surgical treatment, requiring secondary surgery;
- •Two tympanoplasty surgery;
- •Typical allergic rhinitis, nasal endoscopy or imaging studies suggest chronic rhinosinusitis, nasal polyps and other short-term eustachian tube function of a greater impact on the disease;
- •poor general health, with severe liver and kidney dysfunction, coagulation disorders, cardiovascular disease, neurological diseases can not tolerate surgery.
结局指标
主要结局
Recurrence rate in chronic otitis media with eustachian tube dysfunction
时间窗: 6months after the surgery
Recurrence rate in chronic otitis media with eustachian tube dysfunction: with BET vs without BET
次要结局
- Hearing change in chronic otitis media with eustachian tube dysfunction(before the surgery, and 6months after the surgery)
- The change of Eustachian tube function using TUBOMANOMETRY (TMM)(before the surgery, and 6months after the surgery)