Otitis Media With EffusionPhase 2NCT00629694
Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
A Phase 2 study testing adenoidectomy, myringotomy, tubes insertion and A-M in people with Otitis Media With Effusion, run by Aghia Sophia Children's Hospital of Athens at 1 site in Greece.
Trial summary
It is not unusual for several children operated for severe adenoid hyperthrophy causing breathing problems to have otitis media with effusion simultaneously. It is unknown whether adenoidectomy, myringotomy and tubes insertion is superior to adenoidectomy and myringotomy alone in terms of otitis media related quality… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- adenoidectomy, myringotomy, tubes insertion and A-M
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2007to May 2009
- Phase
- Phase 2
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children operated for their adenoid hyperthrophy with an adenoid size of 3 (measured in a scale of 1-3 intraoperatively or from lateral neck x-ray) and otitis media with effusion causing an average air-bone gap of greater than 20db. Children should be otherwise healthy with an ASA score of I and between 3-12 years old of age
Who cannot join
- other health problems especially related with the condition eg cleft palate
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Otolaryngology-Head and Neck Surgery, Aghia Sophia Children's Hospital of Athens
Athens
About this study
It is not unusual for several children operated for severe adenoid hyperthrophy causing breathing problems to have otitis media with effusion simultaneously. It is unknown whether adenoidectomy, myringotomy and tubes insertion is superior to adenoidectomy and myringotomy alone in terms of otitis media related quality of life and recurrence of otitis media several months after the operation. For this purpose a randomized trial is conducted including children operated for adenoid hyperthrophy and whose otitis media with effusion had caused minimal or no symptoms so far
- Conditions
- Otitis Media With Effusion
- Being tested
- adenoidectomy, myringotomy, tubes insertion, A-M
- Keywords
- adenoidectomy, myringotomy, tubes insertion, otitis media, adenoid hyperthophy
- 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.
adenoidectomy, myringotomy, tubes insertionProcedure or surgery
adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M)
A-MProcedure or surgery
adenoidectomy and myringotomy alone
| Study group | Role | What they receive |
|---|---|---|
| A-T | Active comparator | Not described Receives: Procedure: adenoidectomy, myringotomy, tubes insertion |
| A-M | Experimental | Not described Receives: Procedure: A-M |
What is being measured
The primary outcome is the main question the study is designed to answer.
OM-6
Measured: one year post operative
Secondary outcomes (1)
tympanogram type B
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aghia Sophia Children's Hospital of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Vlastos, Aghia Sophia Children's Hospital of Athens
- Investigators
- Ioannis M Vlastos, MD, Principal investigator, Aghia Sophia Children's Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629694
- Sponsor's protocol ID
- 12-01-07
- Status last verified
- Jan 2012
- First submitted
- 27 Feb 2008
- Last updated
- 23 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
- ClinicalTrials.gov ID
- NCT00629694
- Acronym / sponsor ID
- 12-01-07
- Conditions
- Otitis Media With Effusion
- Keywords
- adenoidectomy, myringotomy, tubes insertion, otitis media, adenoid hyperthophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Aghia Sophia Children's Hospital of AthensUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 6 Mar 2008 (estimated)
- 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.
It is not unusual for several children operated for severe adenoid hyperthrophy causing breathing problems to have otitis media with effusion simultaneously. It is unknown whether adenoidectomy, myringotomy and tubes insertion is superior to adenoidectomy and myringotomy alone in terms of otitis media related quality of life and recurrence of otitis media several months after the operation. For this purpose a randomized trial is conducted including children operated for adenoid hyperthrophy and whose otitis media with effusion had caused minimal or no symptoms so far
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-T | Active comparator | Procedure: adenoidectomy, myringotomy, tubes insertion |
| A-M | Experimental | Procedure: A-M |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children operated for their adenoid hyperthrophy with an adenoid size of 3 (measured in a scale of 1-3 intraoperatively or from lateral neck x-ray) and otitis media with effusion causing an average air-bone gap of greater than 20db. Children should be otherwise healthy with an ASA score of I and between 3-12 years old of age
Key exclusion criteria (1 listed)
- other health problems especially related with the condition eg cleft palate
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 |
|---|---|---|
| adenoidectomy, myringotomy, tubes insertionadenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M) | Procedure or surgery | A-T |
| A-Madenoidectomy and myringotomy alone | Procedure or surgery | A-M |
Primary outcome
OM-6
Time frame: one year post operative
1 secondary outcome
tympanogram type B
Time frame: one year
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 23 Jan 2012.
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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.
Ioannis M Vlastos, MD principal investigator
Aghia Sophia Children's Hospital of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adenoidectomy, myringotomy, tubes insertion and A-M in people with Otitis Media With Effusion, run by Aghia Sophia Children's Hospital of Athens at 1 site in Greece.
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 1 inclusion and 1 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 23 Jan 2012. 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 Greece. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
OM-6 (time frame: one year post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2012.