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临床试验/NCT03082170
NCT03082170Unknown不适用

Quality of Postoperative Swallowing After Tongue Base and Palate Surgeries for Obstructive Sleep Apnea.

Rambam Health Care Campus0 个研究点目标入组 120 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
主要终点
SDQ

研究概览

简要总结

The investigators hypothesize that partial robotic tongue base resection surgery and / or soft palate surgery, as a treatment for sleep apnea affect the swallowing quality.In order to characterize the dysphagia The investigators will locate participants undergoing this surgery more than six months ago.The investigators will test their swallowing by fiberoptic endoscopic evaluation of swallowing (FEES) and let participants fill out a questionnaire regarding swallowing disorders swallowing dysfunction questionnaire (SDQ). Also the investigators will use data collected from participants who have undergone this surgery and already had these tests due to swallowing complaints.

详细描述

first step: The investigators will review the operating room reports, identify participants who underwent trans-oral robotic surgery for base of tongue and/ or soft palate surgery more than six months ago.

second step:

  1. The investigators will locate and conclude data of participants who already underwent assessment of postoperative swallowing function (FEES test and SDQ).The investigators will review the summary of their meeting.
  2. The investigators will Call participants who have not yet done swallowing assessment and invite them to a clinic appointment.

third step- participants come to the clinic. Receive an explanation, sign a consent form. Then the participants fulfill the SDQ questionnaire (patient self- filling questionnaire) in which the participants assess the quality swallowing.

Then the investigators will conduct the swallowing test - FEES test. During This test fiber optic fiber is inserted through the participants nose for the purpose of observing the pharyngeal and laryngeal areas.The participants eat and drink food and with different textures while looking for their swallowing mechanism via the optical fiber in order to identify swallowing problems.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • participants above 18 years who had Robotic base of tongue surgery and/or soft palate surgery as a treatment for obstructive sleep apnea.

排除标准

  • participants who previously underwent surgery or treatments known to be hazardous for swallowing.
  • participants suffering from a neurological problem that affects the quality of swallowing.
  • Tracheostomized participants.

结局指标

主要结局

SDQ

时间窗: Six months post op

Examination of test scores received in the SDQ

penetration aspiration scale

时间窗: Six months post operative

Examination of test scores received in the penetration aspiration scale

swallowing performance status scale

时间窗: Six months post operative

Examination of test scores received in the swallowing performance status scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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