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

Otitis Clinical Trial

— ConVenTu  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831985
• Other study ID #: ISM-INM/2015/03-1
• Status: Completed
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: November 1, 2023

Study information

• Verified date: October 2023
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Otitis

Intervention

Procedure:
• general practice follow-up
Post-surgery follow-up by general practitioner
• ear-nose-throat (ENT) specialist follow-up
Post-surgery follow-up by ear-nose-throat (ENT) specialist

Locations

Country	Name	City	State
Norway	Ålesund Sykehus	Ålesund
Norway	Sykehuset Innlandet Gjøvik	Gjøvik
Norway	Kristansund Sykehus	Kristiansund
Norway	Molde Sykehus	Molde
Norway	Stavanger Sykehus	Stavanger
Norway	St Olavs Hospital, ØNH-Avdelingn	Trondheim

Sponsors (7)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Alesund Hospital, Helse Stavanger HF, Kristiansund Hospital, Molde Hospital, St. Olavs Hospital, Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	audiogram	pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz	2 years
Primary	audiogram	pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz	4 years