Prospective, multicenter, randomized, controlled clinical study to evaluate the effectiveness of Eustachian tube surgical intervention in the treatment of chronic secretory otitis media

The Sixth Medical Center of PLA General Hospital0 个研究点目标入组 480 人开始时间: 2021年7月8日最近更新: 2024年5月21日

试验速览

暂无简介。

•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.
•3. History of chronic secretory otitis media greater than 3 months.
•4. Complete tympanic membrane with clear middle ear effusion on otoscopic examination.
•5. Conductive deafness.
•6. Acoustic conduction resistance with type B or C curve.
•7. Negative for Valsalva.
•8. History of previous tympanic membrane puncture or medication (nasal spray hormone and/or mucus promoter, etc.).
•9. 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.

•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.

发起方

The Sixth Medical Center of PLA General Hospital