ASSESMENT OF TONSIL VOLUME WITH ULTRASONOGRAPHY IN BOTH CHILDREN AND ADULTS

NCT ID: NCT04030156

Last Updated: 2019-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-04-01

Brief Summary

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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

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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

Conditions

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OSAS Recurrent Tonsillitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

tonsillectomy

Intervention Type PROCEDURE

Tonsillectomy was performed under general anesthesia using cold dissection method.

Actual tonsil volume

Excised tonsil volumes were calculated by water replacement method.

tonsillectomy

Intervention Type PROCEDURE

Tonsillectomy was performed under general anesthesia using cold dissection method.

Interventions

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tonsillectomy

Tonsillectomy was performed under general anesthesia using cold dissection method.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-Tonsillectomy patients with suspected malignancy
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Erdem Mengi

Assistant Professor of Otorhinolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erdem Mengi

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University School of Medicine, Denizli, Turkey

Locations

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Erdem Mengi

Denizli, Pamukkale, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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60116787-020/56040

Identifier Type: -

Identifier Source: org_study_id

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