Observation or Otolaryngology Surveillance After Ventilation Tube Insertion in Children: The ConVenTu Noninferiority Randomized Clinical Trial.

Abstract

Middle-ear ventilation tube (VT) insertion is the most common ambulatory surgery in children. Follow-up for these patients may continue for 2 or more years and consume a great deal of health care resources. Research into the appropriate level of care for such controls is lacking. To determine whether observation by general practitioners (GPs) yielded noninferior audiometric outcomes 2 years after VT insertion compared to otorhinolaryngology (ear, nose, and throat [ENT]) follow-up by specialist health care services. In the multicenter ConVenTu (Control of Ventilation Tubes) noninferiority randomized clinical trial, patients from 6 Norwegian ENT departments were assessed for eligibility from August 15, 2017, to August 30, 2021. Children between 3 and 10 years of age requiring VT insertion were eligible for the study. Patients with comorbidities or hearing loss exceeding 50 dB in at least 1 ear were excluded. The data were analyzed between February 19, 2024, and May 24, 2024. Observation by the patient's GP. The primary outcome was the difference between the means of pure-tone averages (PTAs) measured at inclusion and 2 years after VT insertion. Children were randomized in blocks of varying sizes with an allocation ratio of 1:1 stratified by study center. Differences were compared between observation and ENT follow-up groups using linear mixed model analysis. Analyses were by intention-to-treat, and a margin of 5 dB was used in the determination of noninferiority. The audiographers responsible for audiometric testing were blinded to patient allocation. Secondary outcomes included audiometric and tympanometric resolution as well as complications registered at control. A total of 305 children requiring VT insertion (median [IQR] age, 4 [3-6] years; 185 [60.7%] male) were included in the trial (153 in GP arm and 152 in ENT arm). Of these, 145 children in each group completed audiometric control at 2 years. Audiometric outcomes of the observation group were found to be noninferior to those who routinely followed up with ENT (0.16 dB [1-sided 97.5% CI lower bound, -1.52 dB]) 2 years after VT insertion, well within the noninferiority threshold of 5 dB. There was also no difference in the total number of patients with complications (odds ratio, 0.67 [1-sided 97.5% CI lower bound, 0.39]). In this randomized clinical trial, postoperative observation in general practice was noninferior to routine follow-up of patients who underwent VT surgery in Norway in terms of audiometric outcomes 2 years after VT insertion in otherwise healthy children. These findings may help guide the allocation of resources in the follow-up of these patients. ClinicalTrials.gov Identifier: NCT02831985.