Efficacy of Balloon Eustachian Tuboplasty in cases of unresolved otitis media with effusion and pars tensa retractions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Clinical efficacy of Balloon Eustachian Tuboplasty in treating refractory otitis media with effusion and pars tensa retractions by Eustachian Tube Dysfunction Quality (ETDQ) Score
研究概览
简要总结
The study will be conducted after getting approval from the protocol review committee and ethics committee. The study will be registered in clinical trial registry India (CTRI). Informed consent/ assent will be taken from all the patients. Patients meeting inclusion criteria will be taken up for Balloon eustachian tuboplasty.
PREOPERATIVE ASSESSMENT
After noting personal data such as age and sex of patient, a detailed history will be noted. Family history and any past treatment history will also be noted. Routine blood investigations, pure tone audiometry and impedence audiometry will be done for all patients preoperatively. The patient will also be given a Eustachian tube dysfunction score test.
Anesthesia fitness and clearance
INTRAOPERATIVE TECHNIQUE
All surgeries will be performed by the same surgeon, under general anesthesia.
The procedure will begin with nasal mucosa decongestion with nasal swabs soaked in adrenaline at a dilution of 1:10000. Balloon Eustachian Tuboplasty will be performed with a Balloon Eustachian Tube dilator. The instrument will be introduced trans nasally into the nasopharyngeal orifice of the ET and the cartilaginous part of the ET. The introduction will be visualized with a trans nasally inserted, rigid endoscope (bent at 30 degree, 4-mm diameter) with high resolution. The balloon will be filled with saline to a target pressure of 10 bar with an insufflation pump. This pressure will be applied for 2 minutes. Then, the saline will be drained. This procedure will be repeated 2 times more and then balloon will be pulled out of the nasal cavity, together with the inserter.
POSTOPERATIVE ASSESSMENT
The patient will be started on topical steroid sprays and valsalva maneuver. The patient will be assessed at 2 months postop using Eustachian tube dysfunction score, Pure tone audiometry and Impedence audiometry which will be compared to preoperative values to check the efficacy of the procedure.
TH
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group of 18 to 60 years with Grade 2 or 3 pars tensa retractions or secretory otitis media not responding to medical management.
排除标准
- •Any previous surgical intervention done on tympanic membrane and Eustachian tube
- •Pars tensa retractions type 4 (Sadé classification)
- •Carotid artery dehiscence
- •Active upper respiratory tract infection and middle ear infections.
结局指标
主要结局
Clinical efficacy of Balloon Eustachian Tuboplasty in treating refractory otitis media with effusion and pars tensa retractions by Eustachian Tube Dysfunction Quality (ETDQ) Score
时间窗: 6 weeks
次要结局
- clinical efficacy of Balloon Eustachian Tuboplasty in treating refractory otitis media with effusion and pars tensa retractions by(1. Comparing pre and post operative impedance audiometry findings)
研究者
Ardhendu Sekhar Kar
Maulana Azad Medical College