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Evaluation of Eustachian Tube Function With 226 and 1000 Hz Probes in Children Undergoing Tonsillectomy ± Adenoidectomy

S

Sumeyra DOLUOGLU

Status

Completed

Conditions

Tympanic Membrane Disorder
Eustachian Tube Dysfunction
Eustachian Tube Dysfunction of Both Ears
Tonsillar Hypertrophy

Treatments

Diagnostic Test: Eustachian tube function test with 226 and 1000 Hz probes

Study type

Observational

Funder types

Other

Identifiers

NCT06577051
SumeyraDoluoglu

Details and patient eligibility

About

In children undergoing tonsillectomy ± adenoidectomy without eustachian dysfunction, the objective is to control tubal functions with tympanometry utilising probes at 226 Hz and 1000 Hz, as well as measuring the ipsilateral and contralateral acoustic reflexes with a 226 Hz probe. An eustachian function test with a 226 Hz probe (automatic Williams test) and play audiometry are to be conducted on young children, while pure tone audiometry is to be conducted on older children, in the preoperative period, on the first day after surgery and in the second week after surgery. The primary objective is to ascertain whether the tubal functions, which are hypothesised to be impaired on the first day, return at the latest in the second week, with all tests evaluating the eustachian tube both directly and indirectly. The secondary objective is to determine whether this recovery occurs earlier with the 226 Hz probe or the 1000 Hz probe.

Enrollment

128 patients

Sex

All

Ages

4 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 4-15 years old child patient
  • No preoperative tubal dysfunction detected in the patient
  • Willingness to participate in the study by the patient and his/her parents
  • The patient has no craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
  • No bleeding disorder or disease

Exclusion criteria

  • <3 years old, >15 years old paediatric patient
  • Tubal dysfunction detected preoperatively
  • Not wanting to participate in the study at any stage of the study
  • The patient has craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
  • Having a bleeding disorder or disease

Trial design

128 participants in 1 patient group

Children undergoing tonsillectomy ± adenoidectomy without tubal dysfunction
Description:
* 4-15 years old child patient * No preoperative tubal dysfunction detected in the patient * Willingness to participate in the study by the patient and his/her parents * The patient has no craniofacial anomaly, genetic disorder, cleft palate-lip anomaly * No bleeding disorder or disease
Treatment:
Diagnostic Test: Eustachian tube function test with 226 and 1000 Hz probes

Trial contacts and locations

1

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Central trial contact

Zuhal Aybuke Gazeloglu, MD; Sumeyra Doluoglu, MD

Data sourced from clinicaltrials.gov

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