Health Condition 1: H681- Obstruction of Eustachian tube
Conditions
Interventions
Intervention1: Balloon dilatation of Eustachian tube BDET arm: After three months of conservative treatment with intranasal steroids(Fluticasone furoate 200 microgram nasal spray twice daily for two m
Sponsors
AIIMS, RAIPUR
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1. Perforation or tympanostomy tube in the tympanic membrane 2. Cholesteatoma, retraction pockets with suspicion of cholesteatoma 3. Adhesive otitis media 4. Visible damage to the auditory ossicles 5. Lack of bone cover of the internal carotid artery documented by Computed tomography (CT) scan 6. Cleft lip and palate 7. 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 8. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TympanometryTimepoint: 1 month, 3 months and 6 months post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 1 month, 3 months, and 6 months post treatment | — |
Countries
India
Contacts
Public ContactSharmistha Chakravarty
AIIMS Raipur
Outcome results
None listed