Comparative study of the therapeutic success of balloondilatation of the Eustachian tube with paracentesis vs. grommets in adult patients with chronic or recurrent otitis media with effusio

Phase 2

• Conditions: H65.3; H69.8; Chronic mucoid otitis media; Other specified disorders of Eustachian tube

• Registration Number: DRKS00011088
• Lead Sponsor: Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde,Kopf- und Halschirurgie Otto Körner

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

effusion at least 6 weeks or minimum 3 times a year
- at least one paracentesis without improvement
- conservative treatment with topical steroids and valsalva at leat 4 weeks
- written consent
- min. 18 years old

Exclusion Criteria

- no visible orificeof the ET
- cleft palate
- lesions in the nasopharynx or suspicion of malignancy
- autoimmune disease
- status after radiation of head and neck region
- younger than 18 years
- no written consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is the curing rate of the chronic otitis media with effusion (defined by status of the eardrumm, history of recurent effusion, tympanometry (type A) 12 month after surgery.)

Secondary Outcome Measures

Name	Time	Method
sconadray outcome is patients satisfaction, improvement of ET function (EDTQ-7 and ETS-7), airbonegap compared to per-intervention data.