NCT02831985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

6.2 years

First QC Date

February 19, 2016

Last Update Submit

October 31, 2023

Conditions

Otitis

Keywords

ChildMiddle ear ventilationFollow-up studiesGeneral practitioners

Outcome Measures

Primary Outcomes (2)

  • audiogram

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

    2 years

  • audiogram

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

    4 years

Study Arms (2)

general practice follow-up

EXPERIMENTAL

post-surgery follow-up by general practitioner

Procedure: general practice follow-up

ENT specialist follow-up

ACTIVE COMPARATOR

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

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

Interventions

general practice follow-upPROCEDURE

Post-surgery follow-up by general practitioner

general practice follow-up
ear-nose-throat (ENT) specialist follow-upPROCEDURE

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

ENT specialist follow-up

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ålesund Sykehus

Ålesund, Norway

Location

Sykehuset Innlandet Gjøvik

Gjøvik, Norway

Location

Kristansund Sykehus

Kristiansund, Norway

Location

Molde Sykehus

Molde, Norway

Location

Stavanger Sykehus

Stavanger, Norway

Location

St Olavs Hospital, ØNH-Avdelingn

Trondheim, Norway

Location

Related Publications (2)

  • Yahiro R, Austad B, Helvik AS, Nilsen AH, Salvesen O, Thorstensen WM. Observation or Otolaryngology Surveillance After Ventilation Tube Insertion in Children: The ConVenTu Noninferiority Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Nov 1;151(11):1063-1070. doi: 10.1001/jamaoto.2025.2880.

    PMID: 41066095DERIVED

  • 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.

    PMID: 33228735DERIVED

MeSH Terms

Conditions

Otitis

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Wencke Moe Thorstensen, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Anne S Helvik, PhD

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2016

First Posted

July 13, 2016

Study Start

August 15, 2017

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

NO(6)