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Completed

NCT Number: NCT04030156

ASSESMENT OF TONSIL VOLUME WITH ULTRASONOGRAPHY IN BOTH CHILDREN AND ADULTS

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Erdem Mengi

Denizli, Pamukkale, 20070, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-Tonsillectomy patients with suspected malignancy

Treatment and study plan

Tonsillectomy

Procedure

Tonsillectomy was performed under general anesthesia using cold dissection method.

Primary outcomes

  1. Clinical tonsil grade

    Time frame: 20 minutes

    Physical examination of patients and tonsil grade assessment using Friedman tonsil grading system were done prior to surgery

  2. mean ultrasonographic tonsil volume (ml)

    Time frame: 20 minutes

    Tonsil volume was calculated with standard ultrasonography formula (height x length x thickness x 0.52) due to its ellipsoid shape

  3. mean actual tonsil volume (ml)

    Time frame: 20 minutes

    Excised tonsil volumes were calculated by water replacement method.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

ASSESSMENT OF TONSIL VOLUME WITH TRANSCERVICAL ULTRASONOGRAPHY IN BOTH CHILDREN AND ADULTS - A PROSPECTIVE CLINICAL RESEARCH

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2019
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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