ASSESMENT OF TONSIL VOLUME WITH ULTRASONOGRAPHY IN BOTH CHILDREN AND ADULTS

Completed

• Conditions: OSAS; Recurrent Tonsillitis

• Registration Number: NCT04030156
• Lead Sponsor: Pamukkale University

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

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-04-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-19
• Study First Submitted QC: 2019-07-19
• Last Update Submitted: 2019-07-22
• Study First Posted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

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

Exclusion Criteria

-Tonsillectomy patients with suspected malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical tonsil grade	20 minutes	Physical examination of patients and tonsil grade assessment using Friedman tonsil grading system were done prior to surgery
mean actual tonsil volume (ml)	20 minutes	Excised tonsil volumes were calculated by water replacement method.
mean ultrasonographic tonsil volume (ml)	20 minutes	Tonsil volume was calculated with standard ultrasonography formula (height x length x thickness x 0.52) due to its ellipsoid shape

Trial Locations

Locations (1)

Erdem Mengi; 🇹🇷 Denizli, Pamukkale, Turkey