Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population

University of Patras

Status: Completed

Conditions: Enlargement of Tonsil or Adenoid

Treatments: Procedure: Tonsillectomy and/or adenoidectomy; Diagnostic Test: Tympanometry; Diagnostic Test: Complete Blood Count

Study type: Observational

Funder types: Other

Identifiers

NCT03541434

14/30-09-2016 CHPatras

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Available history and physical exam findings
• Available complete blood count and tympanometry at admission

Exclusion criteria

• Previous tonsillectomy and/or adenoidectomy.
• Previous ear surgery.
• Acute infection during the past month.
• Active severe systemic disease.

Trial design

134 participants in 4 patient groups

Healthy

Description:

Children with no history of adenotonsillar hypertrophy, recurrent tonsillitis, or middle ear effusion. They presented to the clinic for examination or a scheduled procedure.

Treatment:

Diagnostic Test: Complete Blood Count

Diagnostic Test: Tympanometry

Recurrent tonsillitis

Description:

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.

Treatment:

Procedure: Tonsillectomy and/or adenoidectomy

Diagnostic Test: Complete Blood Count

Diagnostic Test: Tympanometry

Middle ear effusion

Description:

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.

Treatment:

Procedure: Tonsillectomy and/or adenoidectomy

Diagnostic Test: Complete Blood Count

Diagnostic Test: Tympanometry

Adenotonsillar hypertrophy

Description:

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.

Treatment:

Procedure: Tonsillectomy and/or adenoidectomy

Diagnostic Test: Complete Blood Count

Diagnostic Test: Tympanometry