NCT02831985: ConVenTu

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

Completed NA Last updated 2 November 2023

What this trial tests

NA trial testing general practice follow-up in Otitis in 322 participants. Completed in 1 November 2023.

Timeline

15 August 2017

Primary endpoint
1 November 2023

1 November 2023

Quick facts

Lead sponsor	Norwegian University of Science and Technology
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	322
Start date	15 August 2017
Primary completion	1 November 2023
Estimated completion	1 November 2023
Sites	6 locations across Norway

Drugs / interventions tested

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

Conditions studied

• Otitis — all drugs for Otitis →

Sponsor

Norwegian University of Science and Technology

Who can join

Adults 3 to 10, any sex, with Otitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Postoperative controls of ventilation tubes in children by general practitioner or otolaryngologist? Study protocol for a multicenter randomized non-inferiority study (The ConVenTu study).
   Austad B, Nilsen AH, Helvik AS, Albrektsen G, et al · · 2020 · cited 3× · PMID 33228735 · DOI 10.1186/s13063-020-04849-3
2. Observation or Otolaryngology Surveillance After Ventilation Tube Insertion in Children: The ConVenTu Noninferiority Randomized Clinical Trial.
   Yahiro R, Austad B, Helvik AS, Nilsen AH, et al · · 2025 · cited 2× · PMID 41066095 · DOI 10.1001/jamaoto.2025.2880