Clinical trial NCT03848026: Tympanostomy Tube Extrusion Time & Viscosity
Official title: The Relationship Between the Tympanostomy Tube Extrusion Time & Viscosity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: OTITIS MEDIA WITH EFFUSION
Keywords: Otitis media
tympanostomy tube
viscosity
middle ear fluid
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 33
Sex: ALL
Minimum age (years): 2
Maximum age (years): 53
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 33 patients who were diagnosed as otitis media with effusion and scheduled for Shepard TT insertion included in the study.

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.

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

Primary outcomes:
measure: Mean tube extrusion time
timeFrame: 2 year
measure: The correlation between tube extrusion time and viscosity
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Nazan Degirmenci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.