ASSESMENT OF TONSIL VOLUME WITH ULTRASONOGRAPHY IN BOTH CHILDREN AND ADULTS

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

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.

Study Overview

• Status: Completed
• Conditions: OSAS; Recurrent Tonsillitis
• Intervention / Treatment: Procedure: tonsillectomy

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 Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Turkey
  • Pamukkale
    • Denizli, Pamukkale, Turkey, 20070
      • Erdem Mengi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-Tonsillectomy patients with suspected malignancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ultrasonographic tonsil volume; All measurements were done by the same radiologist with over 20 years of experience. GE LOGIQ E9 (GE Healthcare, Milwaukee, WI, USA) was used in USG examination. The patients were viewed using a 2-9 MHz linear probe from the submental region. The examination was done while the patient was in a supine position, with a neck support. Right tonsil measurement was done by turning the neck slightly to the upper left whereas left tonsil measurement was done by turning the neck slightly to the upper right. Tonsil volume was calculated with standard ultrasonography formula (height x length x thickness x 0.52) due to its ellipsoid shape.	Procedure: tonsillectomy; Tonsillectomy was performed under general anesthesia using cold dissection method.
Actual tonsil volume; Excised tonsil volumes were calculated by water replacement method.	Procedure: tonsillectomy; Tonsillectomy was performed under general anesthesia using cold dissection method.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Erdem Mengi, Pamukkale University School of Medicine, Denizli, Turkey

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: ultrasonography; tonsillectomy; tonsil; Size
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Tonsillitis
• Other Study ID Numbers: 60116787-020/56040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No