OTITIS MEDIA WITH EFFUSIONNCT03848026
Tympanostomy Tube Extrusion Time & Viscosity
An observational study of OTITIS MEDIA WITH EFFUSION, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 53 years
- Conditions the study is for
- OTITIS MEDIA WITH EFFUSION
- What is being tested?
- Middle ear fluid viscosity and Tympanostomy tube extrusion time
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2018to 25 Jun 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 53 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 33 patients who were diagnosed as otitis media with effusion and scheduled for Shepard TT insertion included in the study.
Who may be able to join
- 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
Who cannot join
- Patients who do not come to their postoperative controls
- existence of a previous history of TT insertion
- existence of a retraction pocket
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
Official title: The Relationship Between the Tympanostomy Tube Extrusion Time & Viscosity
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).
Read the 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.
- Conditions
- OTITIS MEDIA WITH EFFUSION
- Being tested
- Middle ear fluid viscosity, Tympanostomy tube extrusion time
- Keywords
- Otitis media, tympanostomy tube, viscosity, middle ear fluid
- Medical subject headings
- Otitis Media with Effusion, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle ear fluid viscosityOther
The patients were subdivided into two groups according to median viscosity level
Tympanostomy tube extrusion timeOther
Tympanostomy tube extrusion time of the all patients recorded prospectively.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | middle ear fluid viscosity <439 centipoise (cP), Tympanostomy tube extrusion time of the all patients recorded prospectively Receives: Other: Middle ear fluid viscosity; Other: Tympanostomy tube extrusion time | |
| Group 2 | middle ear fluid viscosity >439 centipoise (cP), Tympanostomy tube extrusion time of the all patients recorded prospectively Receives: Other: Middle ear fluid viscosity; Other: Tympanostomy tube extrusion time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean tube extrusion time
Mean tube extrusion time of total 33 patients was measured
Measured: 2 year
The correlation between tube extrusion time and viscosity
The correlation between tube extrusion time and viscosity was analyzed
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start15 Jan 2018
- Primary completion15 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OTITIS MEDIA WITH EFFUSIONStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazan Degirmenci, Bezmialem Vakif University
- Investigators
- Nazan Degirmenci, MD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848026
- Sponsor's protocol ID
- B.30.2.BAV.0.05.05/468
- Status last verified
- Aug 2019
- First submitted
- 19 Feb 2019
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32554135
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Tympanostomy Tube Extrusion Time & Viscosity
- ClinicalTrials.gov ID
- NCT03848026
- Acronym / sponsor ID
- B.30.2.BAV.0.05.05/468
- Conditions
- OTITIS MEDIA WITH EFFUSION
- Keywords
- Otitis media, tympanostomy tube, viscosity, middle ear fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Middle ear fluid viscosity, Other: Tympanostomy tube extrusion timemiddle ear fluid viscosity <439 centipoise (cP), Tympanostomy tube extrusion time of the all patients recorded prospectively |
| Group 2 | – | Other: Middle ear fluid viscosity, Other: Tympanostomy tube extrusion timemiddle ear fluid viscosity >439 centipoise (cP), Tympanostomy tube extrusion time of the all patients recorded prospectively |
Who may qualify
- Ages
- 2 to 53 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 33 patients who were diagnosed as otitis media with effusion and scheduled for Shepard TT insertion included in the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who do not come to their postoperative controls
- existence of a previous history of TT insertion
- existence of a retraction pocket
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Middle ear fluid viscosityThe patients were subdivided into two groups according to median viscosity level | Other | Group 1, Group 2 |
| Tympanostomy tube extrusion timeTympanostomy tube extrusion time of the all patients recorded prospectively. | Other | Group 1, Group 2 |
Primary outcome
Mean tube extrusion time
Time frame: 2 year
Mean tube extrusion time of total 33 patients was measured
The correlation between tube extrusion time and viscosity
Time frame: 2 year
The correlation between tube extrusion time and viscosity was analyzed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Derived from this study: PubMed 32554135Degirmenci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazan Degirmenci, MD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OTITIS MEDIA WITH EFFUSION, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean tube extrusion time (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03848026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.