Otitis Media With Effusion Clinical Trial
Official title:
Comparison Between the Fate of Secretory Otitis Media in Patients With Adenoids Hypertrophy Undergoing Adenoidectomy Alone or With Myringotomy or With Myringotomy and Tympanostomy Tube Application
This study aims to compare the fate of Secretory Otitis Media in patients with adenoids hypertrophy undergoing Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | December 2022 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Any case presented with Secretory Otitis Media with adenoids hypertrophy with the following criteria - Age is between 3 to 17 years old - With or without chronic tonsillitis - conductive hearing loss - Recurrent upper respiratory tract infection - Dull tympanic membrane on otoscopy (absent cone of light), decreased mobility of tympanic membrane - Type B tympanogram on tympanometry - OME not responding to medical treatment for three months Exclusion Criteria: - Patients with the following criteria will be excluded from the study - Previous Myringotomy with or without Tympanostomy Tube application - Previous adenoidectomy or tonsillectomy - Previous ear surgery, cleft palate, Down's syndrome, congenital malformation of the ear and cholesteatoma. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Hao J, Chen M, Liu B, Yang Y, Liu W, Ma N, Han Y, Liu Q, Ni X, Zhang J. Compare two surgical interventions for otitis media with effusion in young children. Eur Arch Otorhinolaryngol. 2019 Aug;276(8):2125-2131. doi: 10.1007/s00405-019-05421-9. Epub 2019 M — View Citation
Popova D, Varbanova S, Popov TM. Comparison between myringotomy and tympanostomy tubes in combination with adenoidectomy in 3-7-year-old children with otitis media with effusion. Int J Pediatr Otorhinolaryngol. 2010 Jul;74(7):777-80. doi: 10.1016/j.ijporl — View Citation
Tian X, Liu Y, Wang M, Liu H. [A systematic review of adenoidectomy in the treatment of otitis media with effusion in children]. Lin Chung Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2014 Apr;29(8):723-5. Review. Chinese. — View Citation
Xu WM, Ye YH. [Effect of tympanostomy tube insertion with adenoidectomy for children with recurrent otitis media with effusion]. Lin Chung Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2016 Dec;30(23):1873-1875. doi: 10.13201/j.issn.1001-1781.2016.23.009. Chinese — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tympanogram | Tympanogram is test to measure the movement of tympanic membrane in response to changes in pressure. | after 3 months of surgery | |
Primary | Audiogram | Audiogram is graph that shows hearing sensitivity | After 3 months of surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03590912 -
Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion
|
Phase 4 | |
Completed |
NCT03611842 -
Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum
|
||
Not yet recruiting |
NCT01421199 -
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
|
N/A | |
Completed |
NCT01202578 -
Evaluation of the Tympanostomy Tube Delivery System
|
Phase 2/Phase 3 | |
Completed |
NCT00629694 -
Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
|
Phase 2 | |
Completed |
NCT00520039 -
Osteopathic Otitis Media Research Study
|
N/A | |
Completed |
NCT00195611 -
Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
|
Phase 4 | |
Not yet recruiting |
NCT05402267 -
The Effects of Exosomes in Otitis Media With Effusion
|
||
Withdrawn |
NCT00736112 -
Food Allergy - Tubes - Adenoids (FATA) Trial
|
N/A | |
Completed |
NCT00546117 -
A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion
|
N/A | |
Withdrawn |
NCT02950311 -
Xylitol for Otitis Media
|
Phase 2/Phase 3 | |
Recruiting |
NCT05324696 -
Autoinflation: Alternative in the Treatment of Otitis Media With Effusion
|
N/A | |
Recruiting |
NCT05353569 -
Coherent Optical Detection of Middle Ear Disease
|
N/A | |
Completed |
NCT02282540 -
Novel Imaging of the Eustachian Tube; Patient Study
|
N/A | |
Not yet recruiting |
NCT03491098 -
The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study
|
Early Phase 1 | |
Completed |
NCT01082029 -
Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children
|
Phase 4 | |
Completed |
NCT00939796 -
Clinical Study of the Tympanostomy Tube Delivery System
|
N/A | |
Recruiting |
NCT06316635 -
Microplastics in Otitis Media With Effusion Material
|
||
Recruiting |
NCT02215681 -
Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study
|
N/A | |
Completed |
NCT02183974 -
Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion
|
N/A |