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临床试验/NCT03848026
NCT03848026已完成不适用

The Relationship Between the Tympanostomy Tube Extrusion Time & Viscosity

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年1月15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
33
试验地点
1
主要终点
The correlation between tube extrusion time and viscosity

研究概览

简要总结

Studies have focused on the factors that influence tympanostomy tube (TT) extrusion may contribute to the management of OME. In this study the investigators aimed to assess the correlation between the TT extrusion time and viscosity of the middle ear fluid. 33 patients scheduled for TT insertion included in the study. During the paracentesis, fluid from the middle ear was obtained, and the viscosity was measured with a viscometer. After the surgery, patients were controlled monthly until the tubes were seen extruded.The analysis of the correlation between tube extrusion time and viscosity was insignificant (p >0.05).

详细描述

45 patients were evaluated in the outpatient clinic of the Bezmialem Vakif University Department of Otorhinolaryngology. OME was diagnosed by endoscopic-otoscopic examination findings and type-B tympanograms. Patients who do not have a previous history of TT insertion and retraction pocket included in the study. They were all scheduled for Shepard TT insertion. 12 patients were excluded for not coming to their postoperative controls properly. Total of 33 patients' data were analyzed in the end. During the paracentesis, myringotomy incision was done at the anteroinferior quadrant. Fluid from the middle ear was obtained by using 22 gauge syringe, and the viscosity was measured with a viscometer. Since the viscosity in most patients was mucoid in appearance, the patients were subdivided into two groups according to median viscosity level to determine whether higher or lower viscosity of the effusion impacted tympanostomy tube extrusion time. Patients with an effusion below and above the median viscosity value of 439 centipoise (cP) were assigned to Group 1 and 2, respectively. After the surgery, patients were controlled monthly until the tubes were seen extruded.Brookfield DV-II+ProCP Viscometer (Brookfield Engineering Laboratories, Inc., Massachusetts, USA) was used for viscosity measurements. This viscometer was able to measure the viscosity of fluid samples as small as 0.5 ml. The results of the viscosity measurements were recorded as cP units. The patients were investigated for any correlation between the viscosity level of the effusion and extrusion time of the TT. Descriptive statistics were presented as mean and standard deviation. T-test was used to estimate the correlation between the parameters. Mann-Whitney U Test was used to compare the two groups. Statistical analyses were conducted with the IBM SSPS 22.0 program. Significance level was set at 0.05 for all tests. All the procedures were approved and performed in accordance with the ethical standards of the relevant national and institutional guidelines on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. Permission for the study was obtained from Institutional Ethics Committee.

研究设计

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

入排标准

年龄范围
2 Years 至 53 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • endoscopic-otoscopic examination findings of serous otitis media
  • type-B tympanograms
  • None existence of a previous history of TT insertion
  • None existence of a retraction pocket

排除标准

  • Patients who do not come to their postoperative controls
  • existence of a previous history of TT insertion
  • existence of a retraction pocket

结局指标

主要结局

The correlation between tube extrusion time and viscosity

时间窗: 2 year

The correlation between tube extrusion time and viscosity was analyzed

Mean tube extrusion time

时间窗: 2 year

Mean tube extrusion time of total 33 patients was measured

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

Nazan Degirmenci

Principal Investigator

Bezmialem Vakif University

研究点 (1)

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