Recurrent Chronic Secretory Otitis Media in Children
Conditions
Interventions
Balloon Dilation Group:Eustachian Tube Balloon Dilation
Tympanostomy tube placement Group:Tympanostomy tube placement
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Participants 6-12 years older are eligible for enrollment, males, or females. 2. Patients had undergone surgical treatment (including tympanic paracentesis, tympanostomy tube placement, or adenoidectomy) for secretory otitis media with recurrence of unilateral aural fullness and hearing loss on the affected side lasting for more than 12 weeks. 3. Patients have all the following clinical indications: a) Tympanometry was performed, and the tympanogram of the affected side reported B/C2. b) Conductive hearing loss on the affected side, PTA(500-4000Hz)20-55dB. c) The average air-bone conduction gap of the above frequencies is at least 10dB. d) Otoendoscopy and CT simultaneously confirmed secretory otitis media. 4. There was no acute upper respiratory tract infection when the patients were included.
Exclusion criteria
Exclusion criteria: 1. Patients requiring simultaneous bilateral otitis media surgery. 2. The operative lateral ear is sensorineural deafness or mixed deafness. 3. The operation side diagnosed adhesive otitis media, cholesteatoma and tympanosclerosis. 4. The patient is during acute otitis media or acute attack of chronic otitis media; or is in the course of an acute upper respiratory infection. 5. Patients with CT diagnosis of presence of surgical side internal carotid artery stenosis. 6. Patients with cleft palate or after cleft palate repair. 7. Patients with craniofacial syndrome or temporomandibular joint dysfunction. 8. History of radiotherapy above the neck; Patients with systemic malignant tumor. 9. Patients had previous Eustachian tube-related surgery; Patients with congenital or secondary atresia of eustachian tube. 10. Patients who cannot tolerate general anesthesia surgery due to poor general condition, such as liver and renal insufficiency. 11. Those who have participated in other clinical studies prior to enrollment and have not met the timeline for the primary study endpoint. 12. Other conditions in which the investigator judged poor compliance or considered inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment efficiency of chronic secretory otitis media at 1 year of follow-up; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tube replacement rate, secretory otitis media recurrence for more than 3 months, with hearing loss can be considered;Incidence of otorrhea;Tympanal perforation rate;ETDQ-7;Recovery rate of Valsalva test;pure tone audiometry;Tympanometry recovery rate; | — |
Countries
China
Contacts
Public ContactLingxiang Hu
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed