Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist?

Study Overview
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Brief Summary
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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.

Detailed Description
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Remark: the change in age range of included children from 4-10 to 3-10 was approved by REK (ethics committee) in November 2018.

Official Title
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Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist? A Multicenter Randomized Controlled Trial (The ConVenTu Study)

Conditions
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Otitis

Intervention / Treatment
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* Procedure: general practice follow-up
* Procedure: ear-nose-throat (ENT) specialist follow-up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: general practice follow-up<br>post-surgery follow-up by general practitioner | Procedure: general practice follow-up<br>* Post-surgery follow-up by general practitioner<br>|
| Active Comparator: ENT specialist follow-up<br>post-surgery follow-up by ear-nose-throat (ENT) specialist | Procedure: ear-nose-throat (ENT) specialist follow-up<br>* Post-surgery follow-up by ear-nose-throat (ENT) specialist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, Middle ear ventilation, Follow-up studies, General practitioners