Eustachian Tube Dysfunction, Retraction of the Pars Tensa of the Tympanic Membrane, Retraction Pocket of the Tympanic Membrane
Conditions
Keywords
Grade 2 retraction of the pars tensa of the tympanic membrane, Grade 3 retraction of the pars tensa of the tympanic membrane
Brief summary
This is a study that aims to evaluate the feasibility of undertaking a United Kingdom (UK) multi-centre randomised controlled trial of BET for the treatment of moderate (grade 2 or 3) retraction pockets (RPs). This future study will aim to address the question: Does BET improve symptoms scores, audiometry and otoscopic appearance of Grade 2-3 pars tensa RPs in adult patients? Currently conservative treatments for this condition has been shown to be ineffective; there is a significant risk of progression to hearing loss or more serious complications in untreated retraction pockets; and the surgical treatments available to us in the UK not only have a number of risks and drawbacks, but also do not aim to treat the underlying cause (Eustachian Tube dysfunction (ETD)).
Interventions
DEVICEBielefeld balloon
Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic
Sponsors
University Hospital Plymouth NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients over 18 years old with grade 2-3 retraction pocket of the tympanic membrane as assessed by study clinician.
Exclusion criteria
* Craniofacial abnormalities (assessed by history and examination) * Cholesteatoma (assessed by history, otoscopy, tympanogram, PTA) * Nasopharyngeal tumours (assessed by flexible nasendoscopy) * Adenoid hypertrophy (assessed by flexible nasendoscopy) * Patulous ET (assessed by history, otoscopy and tympanogram) * Previous middle ear surgery (assessed by history and otoscopy) * Concurrent use of anticoagulant medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 6 months | Acceptability of the procedure, which will be assessed with pre- and post-procedure using the the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7). |
| Patient Focus Group | 6 months | Thematic analysis of Patient Focus Group discussions. Standardised questions and focus group discussion with patients with (i) un-operated asymptomatic Retraction Pockets (RPs), (ii) un-operated symptomatic RPs, (iii) RPs treated with cartilage tympanoplasty, and (iv) RPs treated with BET. These will qualitatively assess (as appropriate) positive and negative aspects of patient experience, such as living with the RP, the procedure itself, their recovery, any after effects, and participating in the study. Focus groups will consist of 6 patients in each group. |
| Complications | 6 months | An assessment of the number of complications in the 20 participants undergoing BET will also be performed as a marker of safety of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability to perform Valsalva | Assessed pre-intervention and post-intervention at 2 weeks and 6 months. | Ability to perform Valsalva measured as always, sometimes or never. Assessed pre-intervention and post-intervention at 2 weeks and 6. |
| Demand | 1 year | Demand assessed by recruitment rate |
| pure-tone average (PTA) hearing loss | Assessed pre-intervention and post-intervention at 2 weeks and 6 months. | PTA (air conduction at 0.25, 0.5, 1, 2, 3, 4, 6, 8kHz; bone conduction at 0.5, 1, 2, 3, 4 kHz) with calculation of air bone gap at 0.5, 1, 2, 3 and 4kHz. Assessed pre-intervention and post-intervention at 2 weeks and 6 months |
| Tympanometry | Assessed pre-intervention and post-intervention at 2 weeks and 6 months. | Tympanometry (peak middle ear pressure and compliance, and Jerger grade (Improved, unchanged, worse)). Assessed pre-intervention and post-intervention at 2 weeks and 6 months. |
| Cost analysis of treatment | 1 year | Cost analysis of BET vs. cartilage tympanoplasty |
| Comparison of otoendoscopy images | Assessed pre-intervention and post-intervention at 2 weeks and 6 months. | Comparison of otoendoscopy images by two experienced observers and computer software (ImageJ). Assessed pre-intervention and post-intervention at 2 weeks and 6 months. |
Countries
United Kingdom
Outcome results
None listed