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临床试验/NCT02926014
NCT02926014已完成不适用

Lingual Tonsil Hypertrophy Grading and Its Relation to Sociodemographic Factors and Clinical Symptoms

Lithuanian University of Health Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Lingual tonsil enlargement grade on videolaryngoscopy

研究概览

简要总结

The aim of this research was to evaluate the lingual tonsil hypertrophy (LTH) grading of patients with dysphagia using videolaryngoscopy and determine the relation of LTH grades to sociodemographic factors and clinical symptoms.

详细描述

Two groups of people were interviewed during this research - the LTH group and the control group - a total of 100 subjects. The first group was comprised of 50 individuals, who visited the otorhinolaryngologist at Lithuanian University of Health Sciences hospital, regarding dysphagia, and were diagnosed with LTH during endoscopy. The second group consisted of 50 healthy individuals without dysphagia, who did not have enlarged lingual tonsils during assessment using videolaryngoscopy. All subjects filled out the questionnaires, composed of RSI (Reflux Symptom Index) and DSQ (Dysphagia Screening Questionnaire) questionnaires, validated and verified for use in Lithuania, together with a questionnaire created specifically for this research for gathering sociodemographic data.

The LTH grade of all subjects was determined using DelGaudio and Friedman grading systems.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consent for participating in the research
  • No cognitive disorders or mental illnesses
  • Complaining about difficulty swallowing (research group)
  • Enlarged lingual tonsils on videolaryngoscopy (research group)
  • Generally healthy, no complaints of swallowing disorders (control group)
  • Normal-sized lingual tonsils (control group)

排除标准

  • Refusal to participate in the research
  • Younger than 18 and older than 80 years old
  • Serious mental or cognitive conditions

结局指标

主要结局

Lingual tonsil enlargement grade on videolaryngoscopy

时间窗: At baseline

Lingual tonsil enlargement grade was assessed using DelGaudio (2008) and Friedman (2015) grading systems during videolaryngoscopy. According DelGaudio severity of LTH was assessed as: grade 0- lingual tonsils are not enlarged; 1- the lingual tonsils are prominent but not in full contact with the epiglottis or obscuring the valleculae; 2- the lingual tonsils obscure the view of the valleculae and are fully in contact with the epiglottis; 3- the lingual tonsils fill the valleculae and partially or fully obscure the view of the epiglottis. Friedman grading system consists of 0 to 4 scale: 0- complete absence of lymphoid tissue; 1- lymphoid tissue scattered over tongue base; 2- lymphoid tissue covering entirety of tongue base with limited vertical thickness; 3- significantly raised lymphoid tissue covering entirety of the tongue base, approximately 5 to 10 mm in thickness; 4- lymphoid tissue rising above the tip of the epiglottis, 10 or more mm in thickness.

次要结局

  • Sociodemographic factors: age(At baseline)
  • Sociodemographic factors: gender(At baseline)
  • Sociodemographic factors: body mass index (BMI)(At baseline)
  • Sociodemographic factors: gastrointestinal diseases(At baseline)
  • Sociodemographic factors: history of fibroesophagogastroduodenoscopy (FEGDS) findings(At baseline)
  • Sociodemographic factors: occupation and employment status(At baseline)
  • Sociodemographic factors: health behaviors(At baseline)
  • Sociodemographic factors: previous tonsillectomy(At baseline)
  • Sociodemographic factors: use of antacids(At baseline)
  • Sociodemographic factors: allergic diseases(At baseline)
  • General health status(At baseline)
  • Reflux Symptom Index questionnaire(At baseline)
  • Dysphagia Screening Questionnaire(At baseline)
  • Symptom severity(At baseline)

研究者

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

Nora Siupsinskiene

Professor medical doctor of otorhinolaryngology

Lithuanian University of Health Sciences

研究点 (1)

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