European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
Comparison of tuboplasty and tympanotomy tube, alone or in combination for the treatment of chronic otitis media with effusion: randomized controlled trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Lou Zihan, Lou Zhengcai, Yu Yuan, Ji Jiaming, Wang Jingjing, Zhang Boya, Hu Yibing, Zhang Yihuan, Chen Zhengnong
Аннотация
OBJECTIVE: The objective of this study was to compare the tympanotomy tube (TT) retention success rates, the chronic otitis media with effusion (COME) recurrence rates, and the complications of radiofrequency tuboplasty only (RT-only), tympanotomy tube insertion (TTI) + RT, and TTI-only, used to treat unilateral chronic otitis media with effusion (COME) in adult associated with hypertrophy of the nasopharyngeal orifice of the Eustachian tube.
MATERIALS AND METHODS: Patients with COME and hypertrophy of the nasopharyngeal orifice were randomly allocated to either an RT-only group or a TTI + RT group or a TTI-only group. The successful treatment rates, TT retention rates, OME recurrence rates, postoperative Eustachian tube (ET) orifice mucosal inflammation (ETI) grades, and complications were evaluated 18 months after surgery.
RESULTS: A total of 156 COME patients were included. The successful treatment rates differed significantly among the three groups (P < 0.01). The TT retention success rate in the TTI + RT group was significantly higher than in the TTI-only group (96.2% vs. 82.7%, P < 0.05). The total TT premature extrusion rates at 6-12 months differed significantly between the TTI + RT and TTI-only groups (P < 0.05). Similarly, the total OME recurrence rates differed significantly among the three groups (P < 0.001). At both 6-12 and 12-18 months, the differences were significant between the TTI-only, and the RT-only and TTI + RT groups (P < 0.05). In the RT-only and TTI + RT groups, the OME recurrence rates of patients with preoperative grade 3 ETI were significantly higher than those of patients with preoperative grade 4 ETI. No RT-related severe adverse event was observed in the RT-only or TTI + RT group. Only three patients developed small red granulomas in the posterior cushion.
CONCLUSIONS: The TTI + RT group exhibited the highest treatment success rate and the most durable outcomes of selected COME patients with hyperplastic ET nasopharyngeal orifices. However, given the small sample size, the short follow-up time, and the co-interventions, future studies with larger cohorts are required to validate the findings. In addition, it is important to explore further whether RT more effectively treats hypertrophic mucosa than hypertrophic cartilage at the nasopharyngeal orifice.
MATERIALS AND METHODS: Patients with COME and hypertrophy of the nasopharyngeal orifice were randomly allocated to either an RT-only group or a TTI + RT group or a TTI-only group. The successful treatment rates, TT retention rates, OME recurrence rates, postoperative Eustachian tube (ET) orifice mucosal inflammation (ETI) grades, and complications were evaluated 18 months after surgery.
RESULTS: A total of 156 COME patients were included. The successful treatment rates differed significantly among the three groups (P < 0.01). The TT retention success rate in the TTI + RT group was significantly higher than in the TTI-only group (96.2% vs. 82.7%, P < 0.05). The total TT premature extrusion rates at 6-12 months differed significantly between the TTI + RT and TTI-only groups (P < 0.05). Similarly, the total OME recurrence rates differed significantly among the three groups (P < 0.001). At both 6-12 and 12-18 months, the differences were significant between the TTI-only, and the RT-only and TTI + RT groups (P < 0.05). In the RT-only and TTI + RT groups, the OME recurrence rates of patients with preoperative grade 3 ETI were significantly higher than those of patients with preoperative grade 4 ETI. No RT-related severe adverse event was observed in the RT-only or TTI + RT group. Only three patients developed small red granulomas in the posterior cushion.
CONCLUSIONS: The TTI + RT group exhibited the highest treatment success rate and the most durable outcomes of selected COME patients with hyperplastic ET nasopharyngeal orifices. However, given the small sample size, the short follow-up time, and the co-interventions, future studies with larger cohorts are required to validate the findings. In addition, it is important to explore further whether RT more effectively treats hypertrophic mucosa than hypertrophic cartilage at the nasopharyngeal orifice.