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

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.

Conditions

• Otitis

Interventions

PROCEDURE

general practice follow-up

Post-surgery follow-up by general practitioner

PROCEDURE

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

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

Sponsors & Collaborators

• St. Olavs Hospital

  collaborator OTHER

• Alesund Hospital

  collaborator OTHER

• Kristiansund Hospital

  collaborator OTHER

• Molde Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Sykehuset Innlandet HF

  collaborator OTHER

• Norwegian University of Science and Technology

  lead OTHER

Principal Investigators

• Wencke Moe Thorstensen, PhD · Norwegian University of Science and Technology

• Anne S Helvik, PhD · Norwegian University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-15

Primary Completion

2023-11-01

Completion

2023-11-01

Countries

• Norway

Study Locations