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A Multicenter Clinical Study on the Efficacy of Eustachian Tube Surgical Intervention in the Treatment of Chronic Secretory Otitis Media

Prospective, Multicenter, Randomized, Controlled Clinical Study to Evaluate the Effectiveness of Eustachian Tube Surgical Intervention in the Treatment of Chronic Secretory Otitis Media

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046672
Enrollment
Unknown
Registered
2021-05-26
Start date
2021-05-26
Completion date
Unknown
Last updated
2022-09-20

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

Conditions

Chronic secretory otitis media

Interventions

Experimental group1:Eustachian Tube Balloon Dilation
Experimental group2:Tympanic Tube Placement
Experimental group3:Eustachian Tube Balloon Dilation Combined with Tympanic Tube Placement

Sponsors

The Sixth Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age 18 to 70 years (including borderline values), with no restriction on gender; 2.Patients diagnosed with chronic secretory otitis media, with no restriction on side, and those who meet the criteria in both ears can be included; (1) History of chronic secretory otitis media greater than 3 months; (2) Complete tympanic membrane with clear middle ear effusion on otoscopic examination; (3) Conductive deafness; (4) Acoustic conduction resistance with type B or C curve. 3.Negative for Valsalva; 4.History of previous tympanic membrane puncture or medication (nasal spray hormone and/or mucus promoter, etc.); 5.Patients who are to be treated with tympanic tube placement or eustachian tube balloon dilation for the first time and meet the indications for the surgery.

Exclusion criteria

Exclusion criteria: 1.Fluctuating sensorineural deafness; 2.Otoscopic examination of the tympanic membrane with adhesions to the tympanic capsule or the presence of otitis externa (oozing from the external ear canal, fungal infection, etc.); 3.Clear presence of abnormal opening of the eustachian tube or other eustachian tube diseases; 4.Eligible for surgical treatment due to other nasal, sinus or ear diseases; 5.History of surgery on the affected middle ear and nasal cavity or nasopharynx; 6.History of cleft palate or other deformities or related surgical repair; 7.History of head or neck surgery or radiation therapy; 8.Patients with ciliary immobility syndrome; 9.Expected survival for malignancy <12 months; 10.Patients with other conditions that, in the opinion of the investigator, are not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Improvement of Eustachian Tube Score 12 months after operation;

Secondary

MeasureTime frame
Recovery rate of Valsalva test;Eustachian Tube Dysfunction Scale;Pure tone audiometry;Morphology of tympanic membrane;Clearance of middle ear effusion;

Countries

China

Contacts

Public ContactHou Zhaohui

The Sixth Medical Center of PLA General Hospital

houstone301@aliyun.com+86 13810700293

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026