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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02831985
Acronym
ConVenTu
Enrollment
322
Registered
2016-07-13
Start date
2017-08-15
Completion date
2023-11-01
Last updated
2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis

Keywords

Child, Middle ear ventilation, Follow-up studies, General practitioners

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.

Interventions

PROCEDUREgeneral practice follow-up

Post-surgery follow-up by general practitioner

PROCEDUREear-nose-throat (ENT) specialist follow-up

Post-surgery follow-up by ear-nose-throat (ENT) specialist

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Alesund Hospital
CollaboratorOTHER
Kristiansund Hospital
CollaboratorOTHER
Molde Hospital
CollaboratorOTHER
Helse Stavanger HF
CollaboratorOTHER_GOV
Sykehuset Innlandet HF
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
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

Design outcomes

Primary

MeasureTime frameDescription
audiogram2 yearspure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026