Table 1 Trial registration data
Data category | Clinical data |
|---|---|
Primary registry | ClinicalTrials.gov NCT02831985 |
Secondary identifying numbers | REC Mid-Norway 2015/902 |
Contact | |
Short title | The ConVenTu study |
Scientific title | Postoperative controls of ventilation tubes in children by general practitioner or otolaryngologist? Study protocol of a multicenter, randomized controlled trial (The ConVenTu study) |
Country of recruitment | Norway |
Population | Children 3–10 years after surgery with VTs |
Study type | Multicenter randomized, non-inferiority study. Randomized into postoperative controls by either otolaryngologists or GP |
Primary purpose | To evaluate whether postoperative care after surgery with VTs performed by GPs represent a sufficient alternative to otolaryngologists |
First enrollment | August 2017 |
Target sample size | 400 |
Primary endpoint | Hearing thresholds 2 years after surgery, measured as pure tone average |
Secondary endpoint | Two years after surgery: Middle ear function assessed with tympanometry and otomicrocopy Complication rates Disease-specific and generic health-related quality of life Guardians evaluations of the postoperative care |