Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population
- Conditions
- Enlargement of Tonsil or Adenoid
- Interventions
- Diagnostic Test: Complete Blood CountDiagnostic Test: TympanometryProcedure: Tonsillectomy and/or adenoidectomy
- Registration Number
- NCT03541434
- Lead Sponsor
- University of Patras
- Brief Summary
Adenotonsillar hypertrophy is the principal cause of obstructive sleep apnea of childhood, yet little is known with regard to its pathophysiologic and molecular mechanisms. The present trial examines potential bioclinical markers of the disease.
- Detailed Description
Background: Tonsils and adenoids comprise the main bulk of Waldeyer's ring, which is commonly enlarged in childhood, until the age of 11. Obstructive sleep apnea caused by adenotonsillar hypertrophy is a major contributing factor to cardiorespiratory morbidity in the pediatric population. It is also responsible for otitis media with effusion, the most frequent cause of children's hearing loss. Even so, there is scarce knowledge of its molecular pathogenesis.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
- Available history and physical exam findings
- Available complete blood count and tympanometry at admission
- Previous tonsillectomy and/or adenoidectomy.
- Previous ear surgery.
- Acute infection during the past month.
- Active severe systemic disease.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy Complete Blood Count Children with no history of adenotonsillar hypertrophy, recurrent tonsillitis, or middle ear effusion. They presented to the clinic for examination or a scheduled procedure. Recurrent tonsillitis Tonsillectomy and/or adenoidectomy 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. Middle ear effusion Complete Blood Count 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. Healthy Tympanometry Children with no history of adenotonsillar hypertrophy, recurrent tonsillitis, or middle ear effusion. They presented to the clinic for examination or a scheduled procedure. Recurrent tonsillitis Complete Blood Count 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. Middle ear effusion Tonsillectomy and/or adenoidectomy 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. Adenotonsillar hypertrophy Tonsillectomy and/or adenoidectomy 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. Recurrent tonsillitis Tympanometry 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. Middle ear effusion Tympanometry 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. Adenotonsillar hypertrophy Complete Blood Count 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. Adenotonsillar hypertrophy Tympanometry 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.
- Primary Outcome Measures
Name Time Method Bioclinical profile of adenotonsillar hypertrophy One year post surgical procedure Clinical, laboratory, and molecular markers of adenotonsillar hypertrophy
- Secondary Outcome Measures
Name Time Method Laboratory markers of adenotonsillar hypertrophy One year post surgical procedure Complete blood count (cells/L)
Clinical markers of adenotonsillar hypertrophy One year post surgical procedure Clinical findings from history (sympoms) and physical exam (signs) suggestive of adenotonsillar hypertrophy.
Wide-Band tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy One year post surgical procedure Resonance frequency of the middle ear (Hz)
Molecular determinants of adenotonsillar hypertrophy One year post surgical procedure Immunohistochemical expression of molecular factors involved in tissue growth (semiquantitative scale)
Tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy One year post surgical procedure Middle ear pressure (dekaPascals)
Trial Locations
- Locations (2)
Patras University Hospital
🇬🇷Rio, Achaia, Greece
Children Hospital of Patras "Karamandaneio"
🇬🇷Patras, Achaia, Greece