Glue Ear, Tube Disorders Eustachian
Conditions
Brief summary
Otitis media with effusion (OME) is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures. Goal of this study will be to evaluate the Balloon Eustachian Tuboplasty (BET) in children as an additional treatment option and to assess long-term effects of BET. Beside the standard procedure, children (4 to 10 years of age), with equal pathology on both ears, will be assigned for BET on side.
Detailed description
Introduction: Otitis media with effusion (OME, glue ear) is very common in children and characterized by fluid in the middle ear without signs or symptoms of acute ear infection. Fluid in the middle ear causes conducting hearing loss. OME has a large impact on health care costs and recurrent or persistent OME can effect the proper development of children. Frequently OME resolves itself, therefore guidelines strongly recommend watchful waiting for 3 months after which treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures. Furthermore there are various short and longterm side-effects of tympanostomy tubes.In Balloon Eustachian Tuboplasty (BET) a ballon catheter is used to dilate the cartilage part of the eustachian tube and is inserted through the nose to reach the opening of the tube, located in the nasopharynx. BET has recently been applied in children for therapy-resistant recurrent OME and inflammatory ear diseases with promising results. Risk and complications rates are very low. Methods: Goal of this study will be the evaluation of Balloon Eustachian Tuboplasty (BET) in children as a primary treatment of OME. Children between the ages of 4 and 10 years with OME and tympanometry type B on both ears, will prospectively be recruited and assigned for adenoidectomy and myringotomy. Parents then will be asked for participation in this trial and fully informed about purpose, technique and possible side effects. If consent is given, adenoidectomy, in case of large adenoids, and myringotomy will be performed on both sides. If necessary (very thick fluid) tympanostomy tubes are placed. One Eustachian tube of each patient is randomly assigned for BET.
Interventions
PROCEDUREBalloon Eustachian Tuboplasty (BET)
A balloon catheter is used to dilate the cartilage part of the eustachian tube and is inserted through the nose to reach the opening of the tube, located in the nasopharynx.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
only surgeon knows treated side, documentation of side only visible to surgeon and investigator
Intervention model description
single-sided treatment, contralateral side with same pathology works as control
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* OME on both sides measured by flat tympanometry
Exclusion criteria
* Patients with cleft lip and/or palate and other severe craniofacial abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tympanometry-Change (Middle ear effusion/eardrum mobility assessed with Tympanometry) | up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively; | Tympanometry, an objective test of middle-ear function, uses variations of air pressure in the ear canal to assess for middle ear effusion / eardrum mobility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Otoscopy score | up to 3 months preoperatively and change to 3, 6 and 9 months postoperatively; | 0= no effusion (Valsalva +/-, not feasible) 1. retracted eardrum 2. Fluid or bubbles through eardrum visible 3. complete fluid blockage of middle ear |
Other
| Measure | Time frame | Description |
|---|---|---|
| symptom-based side depended questionnaire | preoperatively and 9 months postoperatively | subjective scale side depended (zero to ten points - low to high disturbance by symptom). Symptoms asked for e.g. ear-fullness, pressure, pain, etc. |
Countries
Austria
Contacts
Primary ContactGerold Besser, M.D.
Backup ContactValerie Dahm, M.D.
Outcome results
None listed