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

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ClinicalTrials.gov Identifier: NCT02831985
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : December 11, 2019
Sponsor:
Collaborators:
St. Olavs Hospital
Alesund Hospital
Kristiansund Hospital
Molde Hospital
Helse Stavanger HF
Sykehuset Innlandet HF
University Hospital of North Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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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.


Condition or disease Intervention/treatment Phase
Otitis Procedure: general practice follow-up Procedure: ear-nose-throat (ENT) specialist follow-up Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist? A Multicenter Randomized Controlled Trial (The ConVenTu Study)
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831985


Contacts
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Contact: Ann Helen Nilsen 0047 72575376 ann.helen.nilsen@stolav.no
Contact: Bjarne Austad, PhD bjarne.austad@ntnu.no

Locations
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Norway
Sykehuset Innlandet Gjøvik Recruiting
Gjøvik, Norway
Kristansund Sykehus Recruiting
Kristiansund, Norway
Molde Sykehus Recruiting
Molde, Norway
Stavanger Sykehus Recruiting
Stavanger, Norway
Tromsø Sykehus Recruiting
Tromsø, Norway
St Olavs Hospital, ØNH-Avdelingn Recruiting
Trondheim, Norway
Contact: Ann Helen Nilsen    0047 99390969      
Ålesund Sykehus Recruiting
Ålesund, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Alesund Hospital
Kristiansund Hospital
Molde Hospital
Helse Stavanger HF
Sykehuset Innlandet HF
University Hospital of North Norway
Investigators
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Principal Investigator: Wencke Moe Thorstensen, PhD Norwegian University of Science and Technology
Study Director: Anne S Helvik, PhD Norwegian University of Science and Technology
More Information
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02831985    
Other Study ID Numbers: ISM-INM/2015/03-1
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Child
Middle ear ventilation
Follow-up studies
General practitioners
Additional relevant MeSH terms:
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Otitis
Ear Diseases
Otorhinolaryngologic Diseases