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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| Alesund Hospital | OTHER |
| Kristiansund Hospital | OTHER |
| Molde Hospital |
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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.
Remark: the change in age range of included children from 4-10 to 3-10 was approved by REK (ethics committee) in November 2018.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| general practice follow-up | Experimental | post-surgery follow-up by general practitioner |
|
| ENT specialist follow-up | Active Comparator | post-surgery follow-up by ear-nose-throat (ENT) specialist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| general practice follow-up | Procedure | Post-surgery follow-up by general practitioner |
|
| Measure | Description | Time Frame |
|---|---|---|
| audiogram | pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz | 2 years |
| audiogram | pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wencke Moe Thorstensen, PhD | Norwegian University of Science and Technology | Principal Investigator |
| Anne S Helvik, PhD | Norwegian University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ålesund Sykehus | Ålesund | Norway | ||||
| Sykehuset Innlandet Gjøvik |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41066095 | Derived | 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. | |
| 33228735 | Derived |
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| OTHER |
| Helse Stavanger HF | OTHER_GOV |
| Sykehuset Innlandet HF | OTHER |
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| ear-nose-throat (ENT) specialist follow-up | Procedure | Post-surgery follow-up by ear-nose-throat (ENT) specialist |
|
| Gjøvik |
| Norway |
| Kristansund Sykehus | Kristiansund | Norway |
| Molde Sykehus | Molde | Norway |
| Stavanger Sykehus | Stavanger | Norway |
| St Olavs Hospital, ØNH-Avdelingn | Trondheim | Norway |
| Austad 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. |
| ID | Term |
|---|---|
| D010031 | Otitis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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