Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
Øya Medical Centre, Trondheim, Norway.
Trials. 2020 Nov 23;21(1):950. doi: 10.1186/s13063-020-04849-3.
Otitis media with effusion is the major cause of acquired hearing problems in children. Some of the affected children need surgery with ventilation tubes in the tympanic membrane to reduce ear complaints and to improve hearing, middle ear function, and health-related quality of life. This is one of the most common ambulatory surgeries performed on children. Postoperative controls are needed to assess that the tubes are functional, to evaluate whether hearing loss has been improved, and to handle potential complications. The follow-up may continue for years and are usually done by otolaryngologists. Nevertheless, there exist no evidence-based guidelines concerning the level of expertise needed for postoperative controls of the ventilation tubes. The aim of this protocol is to describe the ConVenTu study that evaluates whether postoperative controls performed by general practitioners (GPs) represent a safe and sufficient alternative to controls performed by otolaryngologists.
METHODS/DESIGN: Multicenter randomized non-inferiority study conducted in clinical settings in seven hospitals located in Norway. Discharged children with ventilation tubes, aged 3-10 years, are allocated randomly to receive postoperative controls by either an otolaryngologist at the hospital where they had ventilation tube surgery or their regular GP. Study participants are enrolled consecutively until 200 patients are included in each group. Two years after surgery, we will compare the pure tone average of hearing thresholds (primary endpoint) and middle ear function, complication rate, health-related quality of life and the parents' evaluations of the postoperative care (secondary endpoints).
This protocol describes the first randomized non-inferiority study of GPs performing postoperative controls after surgery with ventilation tubes. Results from this study may be utilized for deriving evidence-based clinical practice guidelines of the level of postoperative controls after ventilation tube surgery which is safe and sufficient.
ClinicalTrials.gov NCT02831985 . Registered on 13 July 2016.
分泌性中耳炎是儿童获得性听力问题的主要原因。一些受影响的儿童需要通过鼓膜置管手术来减轻耳部不适，改善听力、中耳功能和健康相关生活质量。这是儿童最常见的门诊手术之一。需要进行术后检查以评估管是否功能正常，评估听力损失是否得到改善，并处理潜在的并发症。这种随访可能会持续多年，通常由耳鼻喉科医生进行。然而，目前没有关于鼓膜置管术后检查所需专业水平的循证指南。本方案旨在描述 ConVenTu 研究，该研究评估由普通科医生（GP）进行的术后检查是否代表一种安全且充分的替代方案，以替代耳鼻喉科医生进行的检查。
方法/设计：在挪威七家医院的临床环境中进行的多中心随机非劣效性研究。将年龄在 3-10 岁、带有通气管的出院儿童随机分配接受两种术后检查方式：在进行通气管手术的医院由耳鼻喉科医生进行检查，或由其常规 GP 进行检查。研究参与者连续入组，直到每组各纳入 200 名患者。术后两年，我们将比较听力阈值纯音平均（主要终点）和中耳功能、并发症发生率、健康相关生活质量以及家长对术后护理的评价（次要终点）。
本方案描述了首例由 GP 进行鼓膜置管术后检查的随机非劣效性研究。该研究的结果可用于制定基于证据的鼓膜置管术后检查水平的临床实践指南，该指南是安全且充分的。
ClinicalTrials.gov NCT02831985。于 2016 年 7 月 13 日注册。
