Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population
NCT ID: NCT03541434
Last Updated: 2019-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
134 participants
OBSERVATIONAL
2017-02-01
2018-06-30
Brief Summary
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Detailed Description
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Objective: Identification of clinical/molecular markers of adenotonsillar enlargement and investigation of their participation in the process of tissue hypertrophy.
Methods: A prospective cohort of children with adenotonsillar hypertrophy were recruited starting on 02/01/2017 and ending on 12/22/2017. Demographic and clinical data including age, gender, sleep apnea severity, tonsillar size, presence of middle ear effusion, family history, review of systems as well as tympanometric and complete blood count results were recorded. Blood samples and tissue specimens from the therapeutic adenotonsillectomy procedure were archived for future analyses. Children with chronic tonsillitis and/or adenoiditis, who also underwent excision of tonsils and/or adenoids served as study controls. Informed consent was obtained from parents of all study participants.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy
Children with no history of adenotonsillar hypertrophy, recurrent tonsillitis, or middle ear effusion. They presented to the clinic for examination or a scheduled procedure.
Complete Blood Count
White blood cell subgroups count
Tympanometry
Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance
Recurrent tonsillitis
Children with a history of recurret tonsillitis but no adenotonsillar hypertrophy. Diagnosis was based on physical exam and complete blood count. They presented to the clinic for a sceduled tonsillectomy.
Complete Blood Count
White blood cell subgroups count
Tympanometry
Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance
Tonsillectomy and/or adenoidectomy
Excision of palatine and/or pharyngeal tonsils.
Middle ear effusion
Children with chronic middle ear effusion but no adenotonsillar hypertrophy. Diagnosis was based on physical exam and tympanometry. They presented to the clinic for scheduled myringotomy with or without adenoidectomy.
Complete Blood Count
White blood cell subgroups count
Tympanometry
Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance
Tonsillectomy and/or adenoidectomy
Excision of palatine and/or pharyngeal tonsils.
Adenotonsillar hypertrophy
Children with tonsillar and/or adenoidal hypertrophy. Diagnosis was based on physical exam and partly on x-ray of nasopharynx or nasopharyngoscopy. They presented to the clinic for scheduled tonsillectomy and/or adenoidectomy.
Complete Blood Count
White blood cell subgroups count
Tympanometry
Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance
Tonsillectomy and/or adenoidectomy
Excision of palatine and/or pharyngeal tonsils.
Interventions
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Complete Blood Count
White blood cell subgroups count
Tympanometry
Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance
Tonsillectomy and/or adenoidectomy
Excision of palatine and/or pharyngeal tonsils.
Eligibility Criteria
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Inclusion Criteria
* Available complete blood count and tympanometry at admission
Exclusion Criteria
* Previous ear surgery.
* Acute infection during the past month.
* Active severe systemic disease.
1 Year
16 Years
ALL
No
Sponsors
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University of Patras
OTHER
Responsible Party
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Georgios Stathopoulos
Associate Professor of Physiology
Principal Investigators
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Georgios T Stathopoulos
Role: PRINCIPAL_INVESTIGATOR
Associate Professor of Physiology
Locations
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Children Hospital of Patras "Karamandaneio"
Pátrai, Achaia, Greece
Patras University Hospital
Rio, Achaia, Greece
Countries
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References
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Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.
Liou HC. Regulation of the immune system by NF-kappaB and IkappaB. J Biochem Mol Biol. 2002 Nov 30;35(6):537-46. doi: 10.5483/bmbrep.2002.35.6.537.
Heneghan AF, Pierre JF, Kudsk KA. JAK-STAT and intestinal mucosal immunology. JAKSTAT. 2013 Oct 1;2(4):e25530. doi: 10.4161/jkst.25530. Epub 2013 Jun 26.
Min HJ, Kim SJ, Kim TH, Chung HJ, Yoon JH, Kim CH. Level of secreted HMGB1 correlates with severity of inflammation in chronic rhinosinusitis. Laryngoscope. 2015 Jul;125(7):E225-30. doi: 10.1002/lary.25172. Epub 2015 Jan 30.
Kourelis K, Marazioti A, Kourelis T, Stathopoulos GT. Haematologic Markers and Tonsil-to-Body Weight Ratio to Assist Adenotonsillar Hypertrophy Diagnosis. Indian J Otolaryngol Head Neck Surg. 2022 Dec;74(Suppl 3):5604-5610. doi: 10.1007/s12070-021-02943-9. Epub 2021 Oct 25.
Other Identifiers
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14/30-09-2016 CHPatras
Identifier Type: -
Identifier Source: org_study_id
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