NCT02831985

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Otitis

Interventions

Type	Name	Description
PROCEDURE	general practice follow-up	Post-surgery follow-up by general practitioner
PROCEDURE	ear-nose-throat (ENT) specialist follow-up	Post-surgery follow-up by ear-nose-throat (ENT) specialist

Timeline

• Start date: 2017-08-15
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2016-07-13
• Last updated: 2023-11-02

Locations

6 sites across 1 country: Norway