ASSESMENT OF TONSIL VOLUME WITH ULTRASONOGRAPHY IN BOTH CHILDREN AND ADULTS

NCT04030156 | Completed

• 1 other identifier: 60116787-020/56040
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

OSAS; Recurrent Tonsillitis

Keywords

Size; tonsil; tonsillectomy; ultrasonography

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Actual tonsil volume

Excised tonsil volumes were calculated by water replacement method.

Procedure: tonsillectomy

Interventions

tonsillectomy PROCEDURE

Tonsillectomy was performed under general anesthesia using cold dissection method.

Actual tonsil volume; ultrasonographic tonsil volume

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Tonsillectomy patients with suspected malignancy

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Erdem Mengi

Denizli, Pamukkale, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tonsillitis

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Erdem Mengi

  Pamukkale University School of Medicine, Denizli, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Otorhinolaryngology

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: February 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: April 1, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)