Postoperative controls of ventilation tubes in children - by general practitioner or otolaryngologist? Study protocol for a multicenter, randomized, controlled trial (The ConVenTu study)
Abstract Background Insertion of ventilation tubes (VTs) in the tympanic membrane is one of the most common ambulatory surgeries performed on children. Postoperative care may continue for two or more years and is today mostly done by otolaryngologists. Controls by general practitioners (GPs) may represent a sufficient level of health care regarding clinical outcome, but there exist no evidence-based guidelines concerning the level of expertise for this task. Aim To evaluate whether postoperative care after surgery with VTs performed by GPs represent a sufficient alternative to otolaryngologists. Methods/design Randomized controlled trial including patients from seven hospitals in all four Regional Health Authorities in Norway. A total of 400 children aged 3-10 years will be randomized to postoperative care by either otolaryngologist or their regular GP after surgery with VTs in the tympanic membrane. Two years after surgery we will compare hearing thresholds, middle ear function, complication rate, health related quality of life as well as the guardians’ evaluations of the postoperative care. Discussion Results from the ConVenTu study are expected to contribute with knowledge necessary to develop evidence-based guidelines regarding the level of expertise for safe postoperative care for children after surgery with VTs.