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临床试验/NCT04030156
NCT04030156已完成不适用

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

Pamukkale University1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
1
主要终点
Clinical tonsil grade

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • Tonsillectomy patients with suspected malignancy

结局指标

主要结局

Clinical tonsil grade

时间窗: 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)

时间窗: 20 minutes

Excised tonsil volumes were calculated by water replacement method.

mean ultrasonographic tonsil volume (ml)

时间窗: 20 minutes

Tonsil volume was calculated with standard ultrasonography formula (height x length x thickness x 0.52) due to its ellipsoid shape

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erdem Mengi

Assistant Professor of Otorhinolaryngology

Pamukkale University

研究点 (1)

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