Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06191562
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-12-19
Brief Title:
Posterior vs Anterior Tympanostomy Tube Placement
Sponsor:
David Chi MD
Organization:
University of Pittsburgh
Study Overview
Official Title:
Randomized Clinical Trial of Post-operative Outcomes Following Posterior Versus Anterior Tympanostomy Tube Placement
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 40000 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 childs 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 childs 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
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 childs 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 childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None