Clinical trial NCT04030156: ASSESMENT OF TONSIL VOLUME WITH ULTRASONOGRAPHY IN BOTH CHILDREN AND ADULTS
Official title: ASSESSMENT OF TONSIL VOLUME WITH TRANSCERVICAL ULTRASONOGRAPHY IN BOTH CHILDREN AND ADULTS - A PROSPECTIVE CLINICAL RESEARCH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: OSAS
Recurrent Tonsillitis
Keywords: Size
tonsil
tonsillectomy
ultrasonography
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both adult and pediatric populations with tonsillectomy indication and diagnosed with recurrent tonsillitis and obstructive sleep apnea syndrome were included in the study

Brief summary: The tonsil volume is an important factor in the decision of the tonsillectomy operation. For this reason, it is important to evaluate the tonsil size before the surgery. Ultrasonography was used in a limited number of studies about tonsil tissue assessment and also those studies include only the pediatric population. In this study, we investigate the success of ultrasonography in adults additionally pediatric population as a contribution to literature.

Detailed description: Tonsillectomy is a common procedure performed on both adults and children. Recurrent tonsillitis, snoring and obstructive sleep apnea is among the most important indications for this surgery. Tonsil volume, in addition to recurrent tonsillitis frequency, are both considered in deciding tonsillectomy operation. Moreover, recent studies showed a correlation between tonsil hypertrophy and tonsillitis frequency. For this reason, a reliable assessment of tonsil volume is crucial both during clinical follow-up and surgery decision.

Today, a number of clinical staging systems are used to assess tonsil volume; with 'Friedman Scale' and 'Brodsky Scale' being the most commonly used systems. Those staging systems employ physical examination and are graded on palatine tonsils' midline extension. In other words, clinical staging uses just the transverse length of tonsils and vertical length and depth are dismissed. In addition, other factors such as patient non-compliance, size of the tongue and tongue base, hyperactive gag reflex and trismus make a clinical assessment difficult. For those reasons, a correct clinical assessment of tonsil volume is not always conceivable.

Ultrasonography (USG) was used in a limited number of studies about tonsil tissue assessment despite high patient compliance, low cost and its non-radioactive nature. Also, those studies include only the pediatric population.In this study, we would like to assess the success of USG in objective measurement of tonsil volume in both pediatric and adult populations and comparison of those results with clinical findings

Eligibility criteria: Inclusion Criteria:

* Tonsillectomy patients with recurrent tonsillitis
* Tonsillectomy patients with obstructive sleep apnea syndrome.

Exclusion Criteria:

-Tonsillectomy patients with suspected malignancy

Primary outcomes:
measure: Clinical tonsil grade
timeFrame: 20 minutes
measure: mean ultrasonographic tonsil volume (ml)
timeFrame: 20 minutes
measure: mean actual tonsil volume (ml)
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Erdem Mengi
state: Pamukkale
Study officials:
affiliation: Pamukkale University School of Medicine, Denizli, Turkey
name: Erdem Mengi
role: PRINCIPAL_INVESTIGATOR
References: