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Clinical Trials/NCT03848026
NCT03848026
Completed
Not Applicable

The Relationship Between the Tympanostomy Tube Extrusion Time & Viscosity

Bezmialem Vakif University1 site in 1 country33 target enrollmentJanuary 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
OTITIS MEDIA WITH EFFUSION
Sponsor
Bezmialem Vakif University
Enrollment
33
Locations
1
Primary Endpoint
The correlation between tube extrusion time and viscosity
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2018
End Date
June 25, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nazan Degirmenci

Principal Investigator

Bezmialem Vakif University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

The correlation between tube extrusion time and viscosity

Time Frame: 2 year

The correlation between tube extrusion time and viscosity was analyzed

Mean tube extrusion time

Time Frame: 2 year

Mean tube extrusion time of total 33 patients was measured

Study Sites (1)

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