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

October 31, 2023 updated by: Norwegian University of Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

322

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Gjøvik, Norway
        • Sykehuset Innlandet Gjøvik
      • Kristiansund, Norway
        • Kristansund Sykehus
      • Molde, Norway
        • Molde Sykehus
      • Stavanger, Norway
        • Stavanger Sykehus
      • Trondheim, Norway
        • St Olavs Hospital, ØNH-Avdelingn
      • Ålesund, Norway
        • Ålesund sykehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: general practice follow-up
post-surgery follow-up by general practitioner
Procedure: general practice follow-up
Post-surgery follow-up by general practitioner
Active Comparator: ENT specialist follow-up
post-surgery follow-up by ear-nose-throat (ENT) specialist
Procedure: ear-nose-throat (ENT) specialist follow-up
Post-surgery follow-up by ear-nose-throat (ENT) specialist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
audiogram
Time Frame: 2 years
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
2 years
audiogram
Time Frame: 4 years
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

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

Investigators

  • Principal Investigator: Wencke Moe Thorstensen, PhD, Norwegian University of Science and Technology
  • Study Director: Anne S Helvik, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2017

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

February 19, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimated)

July 13, 2016

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISM-INM/2015/03-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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