Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist? (ConVenTu)
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ClinicalTrials.gov Identifier: NCT02831985 |
Recruitment Status :
Recruiting
First Posted : July 13, 2016
Last Update Posted : December 11, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Otitis | Procedure: general practice follow-up Procedure: ear-nose-throat (ENT) specialist follow-up | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist? A Multicenter Randomized Controlled Trial (The ConVenTu Study) |
Actual Study Start Date : | August 15, 2017 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | April 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: general practice follow-up
post-surgery follow-up by general practitioner
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Procedure: general practice follow-up
Post-surgery follow-up by general practitioner |
Active Comparator: ENT specialist follow-up
post-surgery follow-up by ear-nose-throat (ENT) specialist
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Procedure: ear-nose-throat (ENT) specialist follow-up
Post-surgery follow-up by ear-nose-throat (ENT) specialist |
- 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

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Ages Eligible for Study: | 3 Years to 10 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831985
Contact: Ann Helen Nilsen | 0047 72575376 | ann.helen.nilsen@stolav.no | |
Contact: Bjarne Austad, PhD | bjarne.austad@ntnu.no |
Norway | |
Sykehuset Innlandet Gjøvik | Recruiting |
Gjøvik, Norway | |
Kristansund Sykehus | Recruiting |
Kristiansund, Norway | |
Molde Sykehus | Recruiting |
Molde, Norway | |
Stavanger Sykehus | Recruiting |
Stavanger, Norway | |
Tromsø Sykehus | Recruiting |
Tromsø, Norway | |
St Olavs Hospital, ØNH-Avdelingn | Recruiting |
Trondheim, Norway | |
Contact: Ann Helen Nilsen 0047 99390969 | |
Ålesund Sykehus | Recruiting |
Ålesund, Norway |
Principal Investigator: | Wencke Moe Thorstensen, PhD | Norwegian University of Science and Technology | |
Study Director: | Anne S Helvik, PhD | Norwegian University of Science and Technology |
Responsible Party: | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier: | NCT02831985 |
Other Study ID Numbers: |
ISM-INM/2015/03-1 |
First Posted: | July 13, 2016 Key Record Dates |
Last Update Posted: | December 11, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Child Middle ear ventilation Follow-up studies General practitioners |
Otitis Ear Diseases Otorhinolaryngologic Diseases |