Randomized Clinical Trial of Post-operative Outcomes Following Posterior Versus Anterior Tympanostomy Tube Placement
Overview
- Phase
- Not Applicable
- Intervention
- Tympanostomy tube
- Conditions
- Not specified
- Sponsor
- David Chi, MD
- Enrollment
- 386
- Locations
- 2
- Primary Endpoint
- Perforation
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
The goal of this randomized clinical trial is to compare the results of ear tube placement in two different parts of the ear drum. The ear drum can be divided into four parts (called quadrants). Ear tubes are usually placed in one section of the ear drum, called the anterior-inferior quadrant. However, tubes can also be placed in another section, called the posterior-inferior quadrant. Ear tubes usually fall out of the ear drum on their own. In most patients, the hole in the ear drum where the tube used to be closes on its own. Sometimes (in about 2% of patients), the hole does not close on its own and might need surgery. We want to study ear tube placement in the posterior-inferior quadrant because surgery to repair a hole in the eardrum is easier in this location.
For this study, children will receive an ear tube in the usual location (anterior-inferior quadrant) in one ear and the new location (posterior-inferior quadrant) in the other ear. Researchers will determine which ear has the new location using random assignment (like flipping a coin). Researchers will collect information about hearing tests, whether there is ear drainage (otorrhea), if the tube is blocked (occluded), and how the ear drum looks for up to 37 months after tube placement. Participants will answer study questions at 2-12 weeks and 6, 12, 18, 24, 30, and 36 months after surgery. These questions will ask about whether tubes have fallen out of the ear drum, whether there is a hole in the ear drum, whether there has been drainage from the ear or other ear symptoms, and whether there have been any visits to the doctor for ear problems.
Researchers will use this information to compare ears with anterior-inferior tube placement and ears with posterior-inferior tube placement to see if there are differences in common complications following tube placement.
Detailed Description
The tympanic membrane can be divided into quadrants: posterior superior, anterior superior, posterior inferior, and anterior inferior. Traditional training dictates that tympanostomy tubes should be placed in the anterior-inferior quadrant, with the thought that this would lead to longer indwelling time in the tympanic membrane, avoidance of damage to the ossicular chain, and prevention of hearing loss due to residual perforation over the round window following tympanostomy tube extrusion. However, more recent work has challenged these assumptions. Notably, there is a 2-16% risk of chronic perforation following tympanostomy tube extrusion, with a proposed annual incidence of more than 40,000 post-tympanostomy tube perforations in the United States each year. While perforations in the posterior tympanic membrane can often be repaired using transcanal approaches, anterior perforations are more likely to require more invasive postauricular or endoaural approaches or canalplasty. To our knowledge, there are no studies reporting outcomes following tympanostomy tube placement in the posterior-inferior quadrant. If this study demonstrates no difference in hearing, tube indwelling time, and sequelae following posterior-inferior placement compared with anterior-inferior, it would allow otolaryngologists greater flexibility to consider patient characteristics such as factors placing them at increased risk for perforation or anatomy of the auditory canal when selecting the section of tympanic membrane in which to place tubes. Upon completion of screening, patients will be randomized using a random number generator in order to have an equal distribution of left and right ears with tympanostomy tubes placed in the anterior and posterior quadrants. Consented patients will receive an ear tube in the usual location (anterior-inferior) in one ear and a new location (posterior-inferior) in the other ear during surgery. Follow-up will include standard-of-care post-operative visits and may be completed at 2-12 weeks and 5-7 months. Clinicians will examine the child's ears and determine whether otorrhea and occlusion are present. During the visit, audiologists may conduct standard of care ear-specific pure tone average, air-bone gap, and sound field audiometry. At these follow-up visits, otolaryngology providers will complete a form describing the status of the tympanic membrane. This will add \<1 minute to the visit. Caregivers will also complete a form asking about the status of their child's tympanostomy tubes and any ear problems their child has experienced since surgery. This will take \<5 minutes to complete. Results of audiology testing will be collected from the electronic medical record. Additional follow-up will include administration of the caregiver questions via phone, mail, or REDCap email at 12, 18, 24, 30, and 36 months. If the child has other follow-up clinic visits prior to 37 months post-surgery, the provider form will be completed again during these visits. Further research activities will include viewing medical charts of the included subjects.
Investigators
David Chi, MD
Associate Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •Ages 6 months -14 years
- •Bilateral tympanostomy tube placement
- •First tympanostomy tubes placement
- •Indication for tympanostomy tube placement is otitis media
Exclusion Criteria
- •Undergoing tympanostomy tube placement for indication other than otitis media
- •Receiving tubes other than Armstrong grommet.
- •Genetic disorder that impacts the craniofacial structure, immune system, or mucosal secretions such as Downs syndrome, Stickler syndrome, Treacher Collins syndrome, other genetic disorder associated with craniofacial anomalies, Severe Combined Immunodeficiency disorder, Cystic Fibrosis, or Primary Ciliary Dyskinesia
- •Patients with craniofacial abnormalities other than plagiocephaly or submucous cleft palate (SMCP)
- •Caregivers who cannot speak, read, or write in English proficiently
- •Prior or current otologic surgery other than tympanostomy tube placement
- •On systemic corticosteroids at the time of enrollment
- •Immunodeficiency (acquired or congenital)
- •Current retraction, cholesteatoma, or middle ear mass
- •Sensorineural hearing loss
Arms & Interventions
Posterior Tympanostomy Tube Left
Patients in whom the left ear is randomized to receive a tympanostomy tube in the posterior-inferior quadrant (new location).
Intervention: Tympanostomy tube
Posterior Tympanostomy Tube Right
Patients in whom the right ear is randomized to receive a tympanostomy tube in the posterior-inferior quadrant (new location).
Intervention: Tympanostomy tube
Outcomes
Primary Outcomes
Perforation
Time Frame: Within 36 months +/- 30 days following tympanostomy tube placement
Percentage of ears with persistent (\>3 month) perforation of the tympanic membrane
Secondary Outcomes
- Provider-observed tympanostomy tubes in place and patent at 2-12 weeks(2-12 weeks following tympanostomy tube placement)
- Perforation requiring surgical intervention(Within 36 months +/- 30 days following tympanostomy tube placement)
- Ability to see through lumen and assess tube patency at 6 months(6 months±30 days following tympanostomy tube placement)
- Parent-reported otorrhea at 2-12 weeks(2-12 weeks following tympanostomy tube placement)
- Provider-observed tube occlusion at 6 months(6 months±30 days following tympanostomy tube placement)
- Provider-observed tympanostomy tubes in place and patent at 6 months(6 months±30 days following tympanostomy tube placement)
- Retained tubes requiring surgical intervention(Within 36 months +/- 30 days following tympanostomy tube placement)
- Atrophy or retraction at tube site(Within 36 months +/- 30 days following tympanostomy tube placement)
- Cholesteatoma(Within 36 months +/- 30 days following tympanostomy tube placement)
- Ability to see through lumen and assess tube patency at 2-12 weeks(2-12 weeks following tympanostomy tube placement)
- Provider-observed tube occlusion at 2-12 weeks(2-12 weeks following tympanostomy tube placement)
- Parent-reported otorrhea at 6 months(6 months±30 days following tympanostomy tube placement)
- Hearing loss(Within 36 months +/- 30 days following tympanostomy tube placement)
- Tube indwelling time before extrusion(Within 36 months +/- 30 days following tympanostomy tube placement)