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 effusion

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 effusion - BETvs.Grommets

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011088

Enrollment

100

Registered

2016-09-13

Start date

2023-04-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

H65.3 H69.8

Interventions

Group 1: BET, paracentesis Group 2: grommets

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Germany

Contacts

Public ContactStefanie Schröder

Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde,Kopf- und Halschirurgie "Otto Körner"

stefanie.schroeder@med.uni-rostock.de0381/4948301

Outcome results

None listed

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