Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist? (ConVenTu)
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|ClinicalTrials.gov Identifier: NCT02831985|
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : December 11, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Otitis||Procedure: general practice follow-up Procedure: ear-nose-throat (ENT) specialist follow-up||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist? A Multicenter Randomized Controlled Trial (The ConVenTu Study)|
|Actual Study Start Date :||August 15, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: general practice follow-up
post-surgery follow-up by general practitioner
Procedure: general practice follow-up
Post-surgery follow-up by general practitioner
Active Comparator: ENT specialist follow-up
post-surgery follow-up by ear-nose-throat (ENT) specialist
Procedure: ear-nose-throat (ENT) specialist follow-up
Post-surgery follow-up by ear-nose-throat (ENT) specialist
- audiogram [ Time Frame: 2 years ]pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
- audiogram [ Time Frame: 4 years ]pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831985
|Contact: Ann Helen Nilsen||0047 email@example.com|
|Contact: Bjarne Austad, PhDfirstname.lastname@example.org|
|Sykehuset Innlandet Gjøvik||Recruiting|
|St Olavs Hospital, ØNH-Avdelingn||Recruiting|
|Contact: Ann Helen Nilsen 0047 99390969|
|Principal Investigator:||Wencke Moe Thorstensen, PhD||Norwegian University of Science and Technology|
|Study Director:||Anne S Helvik, PhD||Norwegian University of Science and Technology|