ASSESMENT OF TONSIL VOLUME WITH ULTRASONOGRAPHY IN BOTH CHILDREN AND ADULTS

Sponsor

Pamukkale University (Other)

Overall Status

Completed

CT.gov ID

NCT04030156

Collaborator

(none)

Enrollment

Location

13.9

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
OSAS Recurrent Tonsillitis	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

85 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Clinical tonsil grade [20 minutes]
Physical examination of patients and tonsil grade assessment using Friedman tonsil grading system were done prior to surgery
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
mean actual tonsil volume (ml) [20 minutes]
Excised tonsil volumes were calculated by water replacement method.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

-Tonsillectomy patients with suspected malignancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erdem Mengi	Denizli	Pamukkale	Turkey	20070

Sponsors and Collaborators

Pamukkale University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Erdem Mengi, Assistant Professor of Otorhinolaryngology, Pamukkale University

ClinicalTrials.gov Identifier:

NCT04030156

Other Study ID Numbers:

60116787-020/56040

First Posted:

Jul 23, 2019

Last Update Posted:

Jul 24, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Erdem Mengi, Assistant Professor of Otorhinolaryngology, Pamukkale University

Additional relevant MeSH terms:

Tonsillitis

Study Results

No Results Posted as of Jul 24, 2019