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Objective <p>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.</p> Materials and methods <p>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.</p> Results <p>A total of 156 COME patients were included. The successful treatment rates differed significantly among the three groups (<i>P</i> &lt; 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%, <i>P</i> &lt; 0.05). The total TT premature extrusion rates at 6–12 months differed significantly between the TTI + RT and TTI-only groups (<i>P</i> &lt; 0.05). Similarly, the total OME recurrence rates differed significantly among the three groups (<i>P</i> &lt; 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 (<i>P</i> &lt; 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.</p> Conclusions <p>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.</p>

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Comparison of tuboplasty and tympanotomy tube, alone or in combination for the treatment of chronic otitis media with effusion: randomized controlled trial

  • 期刊论文

  • 发表日期：

    2026年5月13日

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  • Zihan Lou,
  • Zhengcai Lou,
  • Yuan Yu,
  • Jiaming Ji,
  • Jingjing Wang,
  • Boya Zhang,
  • Yibing Hu,
  • Yihuan Zhang,
  • Zhengnong Chen

摘要

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.