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NCT Number: NCT02831985

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

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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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sykehuset Innlandet Gjøvik, Gjøvik, Norway

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

general practice follow-up

Procedure

Post-surgery follow-up by general practitioner

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

Procedure

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

Primary outcomes

  1. audiogram

    Time frame: 2 years

    pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz

  2. audiogram

    Time frame: 4 years

    pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Alesund Hospital
  • Helse Stavanger HF
  • Kristiansund Hospital
  • Molde Hospital
  • St. Olavs Hospital
  • Sykehuset Innlandet HF

Registry information

Official study title

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

Acronym: ConVenTu

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2016
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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