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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2023-11-01

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.

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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.

Conditions

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Otitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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general practice follow-up

post-surgery follow-up by general practitioner

Group Type EXPERIMENTAL

general practice follow-up

Intervention Type PROCEDURE

Post-surgery follow-up by general practitioner

ENT specialist follow-up

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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general practice follow-up

Post-surgery follow-up by general practitioner

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No