背景:渗出性中耳炎(OME)是耳部常见疾病,鼻子,和以听觉饱满度和听力损失为特征的咽喉诊所,主要由咽鼓管功能障碍(ETD)引起。鼓膜置管术(TTI)是一种传统的手术治疗选择,可以减轻症状,但不能提供明确的治疗。而且容易复发.球囊扩张咽鼓管成形术(BDET)已成为治疗ETD的新方法,在解决上述限制方面表现出巨大的潜力。然而,它在临床上尚未广泛使用,很少有高质量的随机临床试验来研究其在OME中的长期疗效和安全性.因此,本研究的目的是验证BDET联合TTI对OME患者的疗效及其提供最终治疗的前景。
方法:这是一个前瞻性的,平行组,单盲,随机对照前瞻性试验。共有124名OME患者将被随机分为A组或B组。A组将接受常规治疗(TTI),而B组将使用BDET治疗以及TTI。结果评估将在基线和第三次进行,6th,12th,手术后24个月.主要结果是咽鼓管功能,将通过咽鼓管功能障碍问卷(ETDQ-7)和咽鼓管评分(ETS)进行测量。次要结果包括中耳功能,听力情况,和生活质量,这将通过声阻抗测量来测量,纯音测听法,和中文版慢性耳朵调查(CCES)。结果变化的主要分析将使用具有重复测量(MMRM)方差分析(ANOVA)的混合模型。
结论:这是第一个在中国人群中进行的前瞻性试验,旨在验证BDET联合TTI治疗对OME患者的长期疗效和安全性。这个平行组,单盲,随机对照试验可能为降低OME的复发率和探索OME患者的最终治愈提供机会.该试验的严格设计增强了研究结果的可靠性,确保对研究问题的有力回答。在未来,研究小组将进一步扩展BDET联合治疗的临床证据和应用。
背景:中国临床试验注册ChiCTR2400079632。2024年1月8日注册,https://www。chictr.org.cn/bin/project/edit?pid=214452。
BACKGROUND: Otitis media with effusion (OME) is a common disease in ear, nose, and throat clinics characterized by aural fullness and hearing loss and mainly caused by eustachian tube dysfunction (ETD). Tympanostomy tube insertion (TTI) is a conventional surgical treatment option that can alleviate symptoms but does not provide a definitive cure, and it is prone to recurrence. Balloon dilation eustachian tuboplasty (BDET) has become a novel procedure for the treatment of ETD, demonstrating significant potential in addressing the aforementioned limitations. However, it is not widely available in the clinic and few high-quality randomized clinical trials was conducted to investigate its long-term efficacy and security in OME. Therefore, the purpose of this study is to verify the efficacy of BDET combined with TTI for patients with OME and its prospects for providing a definitive cure.
METHODS: This is a prospective, parallel-group, single-blind, randomized controlled prospective trial. Totally 124 patients with OME will be randomized into either group A or B. Group A will receive conventional therapy (TTI) while group B will use BDET therapy in addition to TTI. Outcome assessments will take place at baseline and at the 3rd, 6th, 12th, and 24th months after surgery. The primary outcome is eustachian tube function, which will be measured by the eustachian tube dysfunction questionnaire (ETDQ-7) and eustachian tube score (ETS). The secondary outcomes include middle ear function, hearing situation, and quality of life, which will be measured by acoustic impedance measurement, pure-tone audiometry, and Chinese-version Chronic Ear Survey (CCES). The main analysis of change in the outcomes will use mixed-model with repeated measures (MMRM) analyses of variance (ANOVAs).
CONCLUSIONS: This is the first prospective trial in Chinese populations that aims to validate the long-term efficacy and safety of BDET-combined TTI therapy in patients with OME. This parallel-group, single-blind, randomized controlled trial may provide an opportunity to decrease the recurrence rate of OME and explore a definitive cure for patients with OME. This trial\'s rigorous design enhances the reliability of the findings, ensuring a robust answer to the research question. In the future, the research team will further expand upon the clinical evidence and applications of the BDET combined therapy.
BACKGROUND: Chinese Clinical Trial Registry ChiCTR2400079632. Registered on 8 January 2024, https://www.chictr.org.cn/bin/project/edit?pid=214452 .