OtitisConVenTuNCT02831985
Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist?
A study testing general practice follow-up and ear-nose-throat (ENT) specialist follow-up in people with Otitis, run by Norwegian University of Science and Technology at 6 sites in Norway.
Trial summary
A large number of children with otitis media undergo surgery with ventilation tubes (VTs) placed in the tympanic membrane. This is done to improve hearing and speech development and to reduce ear complaints. The long-term results of VTs are unclear. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Otitis
- What is being tested?
- general practice follow-up and ear-nose-throat (ENT) specialist follow-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 6 sitesNorway
- Study dates
- 15 Aug 2017to 1 Nov 2023
- Phase
- Interventional
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Insertion of a ventilation tube in at least one ear
- patient at Trondheim University Hospital, Molde Hospital, Aalesund Hospital, Kristiansund Hospital, Stavanger Hospital, Hospital North Norway, or Innlandet Hospital in Gjøvik.
Who cannot join
- Medical syndromes or other co-existing severe disease that possibly result in increased complication rate after insertion of ventilation tubes, i.e. Downs Syndrome, Cystic Fibrosis, Primary Ciliary Dyskinesia
- Auditory processing disorder (APD)
- Severe neurogenic hearing loss (HL) at least one ear (> 50dB HL in frequencies 0.25 - 4.0 KHz)
- Guardians or children who do not master the Norwegian language
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Norway6 sites
Ålesund Sykehus
Ålesund
Sykehuset Innlandet Gjøvik
Gjøvik
Kristansund Sykehus
Kristiansund
Molde Sykehus
Molde
Stavanger Sykehus
Stavanger
St Olavs Hospital, ØNH-Avdelingn
Trondheim
About this study
Official title: Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist? A Multicenter Randomized Controlled Trial (The ConVenTu Study)
A large number of children with otitis media undergo surgery with ventilation tubes (VTs) placed in the tympanic membrane. This is done to improve hearing and speech development and to reduce ear complaints. The long-term results of VTs are unclear. Follow-up care is required to assure that the tubes are functional, hearing loss has been corrected, and potential complications are properly diagnosed and managed. Guidelines regarding follow-up care give different advices concerning when, how and by whom the controls should be made.
The primary goal of this study is to investigate if follow-up care after surgery with VTs of children aged 3-10 years can be done by general practitioners instead of specialists without negative consequences for the patient.
Read more
In the study the child's hearing and speech development, middle ear function, subjective complaints and complications will be assessed. User satisfaction and other aspects related to the quality of control will also be assessed.
If the study shows that follow-ups after surgery with VTs can be done on the level of primary care without loss of care quality, specialist health care services will be spared and cost-effectiveness for the overall healthcare system will improve.
Read the detailed description
Remark: the change in age range of included children from 4-10 to 3-10 was approved by REK (ethics committee) in November 2018.
- Conditions
- Otitis
- Being tested
- general practice follow-up, ear-nose-throat (ENT) specialist follow-up
- Keywords
- Child, Middle ear ventilation, Follow-up studies, General practitioners
- Medical subject headings
- Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general practice follow-upProcedure or surgery
Post-surgery follow-up by general practitioner
ear-nose-throat (ENT) specialist follow-upProcedure or surgery
Post-surgery follow-up by ear-nose-throat (ENT) specialist
| Study group | Role | What they receive |
|---|---|---|
| general practice follow-up | Experimental | post-surgery follow-up by general practitioner Receives: Procedure: general practice follow-up |
| ENT specialist follow-up | Active comparator | post-surgery follow-up by ear-nose-throat (ENT) specialist Receives: Procedure: ear-nose-throat (ENT) specialist follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
audiogram
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
Measured: 2 years
audiogram
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start15 Aug 2017
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OtitisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Alesund Hospital, Kristiansund Hospital, Molde Hospital, Helse Stavanger HF, Sykehuset Innlandet HF
- Responsible party
- Sponsor
- Investigators
- Wencke Moe Thorstensen, PhD, Principal investigator, Norwegian University of Science and TechnologyAnne S Helvik, PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831985
- Sponsor's protocol ID
- ISM-INM/2015/03-1
- Acronym
- ConVenTu
- Status last verified
- Oct 2023
- First submitted
- 19 Feb 2016
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yahiro R, Austad B, Helvik AS, Nilsen AH, Salvesen O, Thorstensen WM. Observation or Otolaryngology Surveillance After Ventilation Tube Insertion in Children: The ConVenTu Noninferiority Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Nov 1;151(11):1063-1070. doi: 10.1001/jamaoto.2025.2880.
PubMed 41066095Austad B, Nilsen AH, Helvik AS, Albrektsen G, Nordgard S, Thorstensen WM. Postoperative controls of ventilation tubes in children by general practitioner or otolaryngologist? Study protocol for a multicenter randomized non-inferiority study (The ConVenTu study). Trials. 2020 Nov 23;21(1):950. doi: 10.1186/s13063-020-04849-3.
PubMed 33228735
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist? A Multicenter Randomized Controlled Trial (The ConVenTu Study)
- ClinicalTrials.gov ID
- NCT02831985
- Acronym / sponsor ID
- ConVenTu / ISM-INM/2015/03-1
- Conditions
- Otitis
- Keywords
- Child, Middle ear ventilation, Follow-up studies, General practitioners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Alesund Hospital, Kristiansund Hospital, Molde Hospital, Helse Stavanger HF, Sykehuset Innlandet HF
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 13 Jul 2016 (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.
A large number of children with otitis media undergo surgery with ventilation tubes (VTs) placed in the tympanic membrane. This is done to improve hearing and speech development and to reduce ear complaints. The long-term results of VTs are unclear. Follow-up care is required to assure that the tubes are functional, hearing loss has been corrected, and potential complications are properly diagnosed and managed. Guidelines regarding follow-up care give different advices concerning when, how and by whom the controls should be made.
The primary goal of this study is to investigate if follow-up care after surgery with VTs of children aged 3-10 years can be done by general practitioners instead of specialists without negative consequences for the patient.
In the study the child's hearing and speech development, middle ear function, subjective complaints and complications will be assessed. User satisfaction and other aspects related to the quality of control will also be assessed.
If the study shows that follow-ups after surgery with VTs can be done on the level of primary care without loss of care quality, specialist health care services will be spared and cost-effectiveness for the overall healthcare system will improve.
Detailed description
Remark: the change in age range of included children from 4-10 to 3-10 was approved by REK (ethics committee) in November 2018.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general practice follow-up | Experimental | Procedure: general practice follow-uppost-surgery follow-up by general practitioner |
| ENT specialist follow-up | Active comparator | Procedure: ear-nose-throat (ENT) specialist follow-uppost-surgery follow-up by ear-nose-throat (ENT) specialist |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Insertion of a ventilation tube in at least one ear
- patient at Trondheim University Hospital, Molde Hospital, Aalesund Hospital, Kristiansund Hospital, Stavanger Hospital, Hospital North Norway, or Innlandet Hospital in Gjøvik.
Key exclusion criteria (4 listed)
- Medical syndromes or other co-existing severe disease that possibly result in increased complication rate after insertion of ventilation tubes, i.e. Downs Syndrome, Cystic Fibrosis, Primary Ciliary Dyskinesia
- Auditory processing disorder (APD)
- Severe neurogenic hearing loss (HL) at least one ear (> 50dB HL in frequencies 0.25 - 4.0 KHz)
- Guardians or children who do not master the Norwegian language
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 |
|---|---|---|
| general practice follow-upPost-surgery follow-up by general practitioner | Procedure or surgery | general practice follow-up |
| ear-nose-throat (ENT) specialist follow-upPost-surgery follow-up by ear-nose-throat (ENT) specialist | Procedure or surgery | ENT specialist follow-up |
Primary outcome
audiogram
Time frame: 2 years
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
audiogram
Time frame: 4 years
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
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 2 Nov 2023.
- Derived from this study: PubMed 41066095Yahiro R, Austad B, Helvik AS, Nilsen AH, Salvesen O, Thorstensen WM. Observation or Otolaryngology Surveillance After Ventilation Tube Insertion in Children: The ConVenTu Noninferiority Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Nov 1;151(11):1063-1070. doi: 10.1001/jamaoto.2025.2880.
- Derived from this study: PubMed 33228735Austad B, Nilsen AH, Helvik AS, Albrektsen G, Nordgard S, Thorstensen WM. Postoperative controls of ventilation tubes in children by general practitioner or otolaryngologist? Study protocol for a multicenter randomized non-inferiority study (The ConVenTu study). Trials. 2020 Nov 23;21(1):950. doi: 10.1186/s13063-020-04849-3.
- Individual participant dataSharing planned: Undecided
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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.
Wencke Moe Thorstensen, PhD principal investigator
Norwegian University of Science and Technology
Anne S Helvik, PhD study director
Norwegian University of Science and Technology
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing general practice follow-up and ear-nose-throat (ENT) specialist follow-up in people with Otitis, run by Norwegian University of Science and Technology at 6 sites in Norway.
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 2 inclusion and 4 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 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Norway. 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?
audiogram (time frame: 2 years). 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 NCT02831985, which also lists 2 linked publications.
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 2 Nov 2023.