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The efficacy of myringotomy and ventilation tube insertion versus observation in postradiation otitis media with effusion

The efficacy of myringotomy and ventilation tube insertion versus observation in postradiation otitis media with effusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20161206001
Enrollment
Unknown
Registered
2016-12-06
Start date
2015-06-11
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postradiation with otitis media with effusion postradiation otitis media with effusion myringotomy with ventilation tube

Interventions

myringotomy with ventilation tube insertion under local anesthesia &#45
2% mepivacaine hydrochloride with adrenaline 1:100&#44
000 is injected in ear canal &#45
myringotomy is done by sickle knife at postero&#45
inferior or antero&#45
inferior quadrant &#45
Paparella type I (firm silicone) is inserted in tympanic membrane,clinical observation at 0&#44
3 and 6 months
myringotomy with ventilation tube,control group

Sponsors

Faculty of Medicine, Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: nasopharyngeal carcinoma patient with otitis media with effusion who finish treatment age 18-75 years old microscopic examination found fluid befind ear drum Audiometry show air-bone gap more than 10 dB Tympanometry type B

Exclusion criteria

Exclusion criteria: patient with ear infection patient with recurrent or residual nasopharyngeal carcinoma

Design outcomes

Primary

MeasureTime frame
complication of treatment 6 months microscopic examination, tympanometry, audiometry,cure rate of otitis media with effusion 6 months microscopic examination, tympanogram, audiometry

Secondary

MeasureTime frame
bone-conduction pure tone average before and after treatment at 3 months and 6 months audiometry,air-bone gap before and after treatment at 3 months and 6 months audiometry

Contacts

Public ContactPaninee Chaursripan

Chulalongkorn University

paninee_c@hotmail.com0886484545

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026