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Effect of balloon dilation eustachian tuboplasty for patients with secretory otitis media

Balloon dilation eustachian tuboplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079632
Enrollment
Unknown
Registered
2024-01-08
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

secretory otitis media

Interventions

Experimental group:Balloon dilation eustachian tuboplasty in addition to conventional surgical procedures.
Control group:Conventional therapy, involving surgical procedures such as adenoidectomy, tympanocentesis, or TTI, depending on individual clinical conditions.

Sponsors

Eye and ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) a confirmed diagnosis of secretory otitis media according to the guideline updated in 2016 by American Academy of Otolaryngology-Head and Neck Surgery Foundation, (2) aged 18 to 80 years, (3) presentation of either tympanic membrane retraction or tympanic effusion, as ascertained through meticulous ear endoscopy, (4) CT scan indicates characteristic findings of secretory otitis media, (5) the confirmation of type B or C tympanograms through the assessment of acoustic impedance.

Exclusion criteria

Exclusion criteria: (1) concurrent manifestation of an upper respiratory tract infection, (2) the presence of documented physiological abnormalities within the ear or nasopharynx, (3) the malformations or aneurysms affecting the ET or the internal carotid artery, as evidenced by high-resolution CT scans, (4) the incapacity to undergo general anesthesia or adhere to scheduled postoperative follow-up appointments, due to factors unrelated to the study's objectives.

Design outcomes

Primary

MeasureTime frame
ET function;Eustachian tube score;

Secondary

MeasureTime frame
Acoustic impedance measurement;Puretone audiometry;Life quality;

Countries

China

Contacts

Public ContactLi Huawei

Eye and ENT Hospital of Fudan University

hwli@shmu.edu.cn+86 189 1778 5659

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026