Clinical trial NCT02831985: Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist?
Official title: Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist? A Multicenter Randomized Controlled Trial (The ConVenTu Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis
Keywords: Child
Middle ear ventilation
Follow-up studies
General practitioners
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Alesund Hospital
name: Kristiansund Hospital
name: Molde Hospital
name: Helse Stavanger HF
name: Sykehuset Innlandet HF
First posted: 2016-07-13
Enrollment: 322
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: audiogram
timeFrame: 2 years
measure: audiogram
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gjøvik
country: Norway
facility: Sykehuset Innlandet Gjøvik
city: Kristiansund
country: Norway
facility: Kristansund Sykehus
city: Molde
country: Norway
facility: Molde Sykehus
city: Stavanger
country: Norway
facility: Stavanger Sykehus
city: Trondheim
country: Norway
facility: St Olavs Hospital, ØNH-Avdelingn
city: Ålesund
country: Norway
facility: Ålesund Sykehus
Study officials:
affiliation: Norwegian University of Science and Technology
name: Wencke Moe Thorstensen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology
name: Anne S Helvik, PhD
role: STUDY_DIRECTOR
References:
citation: 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.