Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist? (ConVenTu)
Primary Purpose
Otitis
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
general practice follow-up
ear-nose-throat (ENT) specialist follow-up
Sponsored by
About this trial
This is an interventional health services research trial for Otitis focused on measuring Child, Middle ear ventilation, Follow-up studies, General practitioners
Eligibility 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
Sites / Locations
- Sykehuset Innlandet Gjøvik
- Kristansund Sykehus
- Molde Sykehus
- Stavanger Sykehus
- Tromsø Sykehus
- St Olavs Hospital, ØNH-Avdelingn
- Ålesund Sykehus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
general practice follow-up
ENT specialist follow-up
Arm Description
post-surgery follow-up by general practitioner
post-surgery follow-up by ear-nose-throat (ENT) specialist
Outcomes
Primary Outcome Measures
audiogram
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
audiogram
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
Secondary Outcome Measures
Full Information
NCT ID
NCT02831985
First Posted
February 19, 2016
Last Updated
September 16, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Alesund Hospital, Kristiansund Hospital, Molde Hospital, Helse Stavanger HF, Sykehuset Innlandet HF, University Hospital of North Norway
1. Study Identification
Unique Protocol Identification Number
NCT02831985
Brief Title
Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist?
Acronym
ConVenTu
Official Title
Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist? A Multicenter Randomized Controlled Trial (The ConVenTu Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Alesund Hospital, Kristiansund Hospital, Molde Hospital, Helse Stavanger HF, Sykehuset Innlandet HF, University Hospital of North Norway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis
Keywords
Child, Middle ear ventilation, Follow-up studies, General practitioners
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
322 (Actual)
8. Arms, Groups, and Interventions
Arm Title
general practice follow-up
Arm Type
Experimental
Arm Description
post-surgery follow-up by general practitioner
Arm Title
ENT specialist follow-up
Arm Type
Active Comparator
Arm Description
post-surgery follow-up by ear-nose-throat (ENT) specialist
Intervention Type
Procedure
Intervention Name(s)
general practice follow-up
Intervention Description
Post-surgery follow-up by general practitioner
Intervention Type
Procedure
Intervention Name(s)
ear-nose-throat (ENT) specialist follow-up
Intervention Description
Post-surgery follow-up by ear-nose-throat (ENT) specialist
Primary Outcome Measure Information:
Title
audiogram
Description
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
Time Frame
2 years
Title
audiogram
Description
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wencke Moe Thorstensen, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne S Helvik, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Sykehuset Innlandet Gjøvik
City
Gjøvik
Country
Norway
Facility Name
Kristansund Sykehus
City
Kristiansund
Country
Norway
Facility Name
Molde Sykehus
City
Molde
Country
Norway
Facility Name
Stavanger Sykehus
City
Stavanger
Country
Norway
Facility Name
Tromsø Sykehus
City
Tromsø
Country
Norway
Facility Name
St Olavs Hospital, ØNH-Avdelingn
City
Trondheim
Country
Norway
Facility Name
Ålesund Sykehus
City
Ålesund
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33228735
Citation
Austad B, Nilsen AH, Helvik AS, Albrektsen G, Nordgard S, Thorstensen WM. Postoperative controls of ventilation tubes in children by general practitioner or otolaryngologist? Study protocol for a multicenter randomized non-inferiority study (The ConVenTu study). Trials. 2020 Nov 23;21(1):950. doi: 10.1186/s13063-020-04849-3.
Results Reference
derived
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Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist?
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