Tympanostomy Tube Extrusion Time & Viscosity
The Relationship Between the Tympanostomy Tube Extrusion Time & Viscosity
1 other identifier
observational
33
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2018
CompletedFirst Submitted
Initial submission to the registry
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2019
CompletedAugust 8, 2019
August 1, 2019
1.4 years
February 19, 2019
August 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean tube extrusion time
Mean tube extrusion time of total 33 patients was measured
2 year
The correlation between tube extrusion time and viscosity
The correlation between tube extrusion time and viscosity was analyzed
2 year
Study Arms (2)
Group 1
middle ear fluid viscosity \<439 centipoise (cP), Tympanostomy tube extrusion time of the all patients recorded prospectively
Group 2
middle ear fluid viscosity \>439 centipoise (cP), Tympanostomy tube extrusion time of the all patients recorded prospectively
Interventions
The patients were subdivided into two groups according to median viscosity level
Tympanostomy tube extrusion time of the all patients recorded prospectively.
Eligibility Criteria
33 patients who were diagnosed as otitis media with effusion and scheduled for Shepard TT insertion included in the study.
You may qualify if:
- 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
You may not qualify if:
- Patients who do not come to their postoperative controls
- existence of a previous history of TT insertion
- existence of a retraction pocket
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakif University
Istanbul, Fatih, 34093, Turkey (Türkiye)
Related Publications (1)
Degirmenci N, Tugrul S, Goktas SS, Senturk E, Calim OF, Dogan R, Yenigun A, Ozturan O. The relationship between the tympanostomy tube extrusion time and viscosity. Int J Pediatr Otorhinolaryngol. 2020 Sep;136:110140. doi: 10.1016/j.ijporl.2020.110140. Epub 2020 May 27.
PMID: 32554135DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nazan Degirmenci, MD
Bezmialem Vakif University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 19, 2019
First Posted
February 20, 2019
Study Start
January 15, 2018
Primary Completion
June 15, 2019
Study Completion
June 25, 2019
Last Updated
August 8, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share