Efficacy of Balloon Dilatation of Eustachian tube (BDET) in conjunction with medical management compared to medical management alone in improvement of Tympanometry, Air Bone gap closure and Eustachian Tube Dysfunction Questionnaire (ETDQ) -7 Scoring in adults with chronic obstructive eustachian tube dysfunction (ETD): Open labelled, randomized, controlled, superiority trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Tympanometry
研究概览
简要总结
This study is a randomized, open labelled, parallel group, superiority trial comparing the Efficacy of Balloon Dilatation of Eustachian tube BDET in conjunction with medical management compared to medical management alone in improvement of Tympanometry, Air Bone gap closure and Eustachian Tube Dysfunction Questionnaire ETDQ 7 Scoring in adults with chronic obstructive eustachian tube dysfunction ETD. All patients attending OPD of the department of ENT and Head Neck Surgery, at our institute with chronic Eustachian Tube Dysfunction ETD will be included in the study. Only those patients who have moderate to severe ETD symptoms based on ETDQ7 scoring and objective findings of retracted tympanic membrane and Type B or C tympanogram will be included as study participants. All the participants will be enrolled in the study after they have received three months of conservative treatment with nasal steroid spray and valsalva maneuvre and have shown persistent ETD after conservative treatment. Consented patients will be allocated into Balloon dilatation group with medical management, which is the intervention group and medical management alone group which will be the control group using computerised Random Allocation Software.
All patients shall be reassessed at I month, 3 month, 6 month intervals for objective assessment of eustachian tube obstruction. The endpoints of the study are Tympanometry, Median change of overall ETDQ 7 score from baseline, Oto-endoscopy and Pure Tone Audiometry at the interval of I month, 3 months, and 6 months post treatment, comparing between the balloon dilatation with medical treatment group and medical treatment alone group. After the records of required sample size has been included, the data will be analysed by appropriate statistical methods of analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 to 60 years, Patients with who have moderate to severe ETD symptoms based on ETDQ 7 scoring and objective findings of retracted tympanic membrane and Type B or C tympanogram will be included as study participants, Patients with chronic ETD who are refractory to two months of conservative treatment of nasal steroids and Valsalva.
- •The ETD was considered refractory when the tympanometry results remained abnormal, either a C or B curve and the otomicroscopy revealed a tympanic membrane categorized as either retracted or with fluid.
排除标准
- •Perforation or tympanostomy tube in the tympanic membrane
- •Cholesteatoma, retraction pockets with suspicion of cholesteatoma
- •Adhesive otitis media
- •Visible damage to the auditory ossicles
- •Lack of bone cover of the internal carotid artery documented by Computed tomography (CT) scan
- •Cleft lip and palate
- •Craniofacial syndrome including Downs syndrome, cystic fibrosis, primary ciliary dyskinesia, systemic immune deficiency, acute otitis media, sinonasal malignancy, prior radiation treatment in the head–neck region, and considerable heart–lung illness
- •Patients were excluded during the study if they received any steroid treatment aside from the study or had a tympanostomy tube inserted or perforated their tympanic membrane.
结局指标
主要结局
Tympanometry
时间窗: 1 month, 3 months and 6 months post treatment
次要结局
- Median change of overall ETDQ 7 score from baseline, Tympanic membrane appearance and Pure Tone Audiometry results are the secondary endpoints to be assessed during interval visits.(1 month, 3 months, and 6 months post treatment)
研究者
Sharmistha Chakravarty
AIIMS Raipur