American journal of rhinology & allergy · 2021
Comparison of Electrocoagulation Tuboplasty and Continued Medical Therapy for Treating Persistent Eustachian Tube Dysfunction With Hypertrophic Mucosa Disease.
Контролируемое клиническое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Tang Yongmei, Lou Zhengcai, Jin Kangfeng, Sun Junzhi, Deng Yue
Аннотация
OBJECTIVES: The objective of this trial was to compare outcomes of electrocoagulation tuboplasty and continued medical therapy for treating persistent Eustachian tube dysfunction (ETD) with hypertrophic mucosa disease in the Eustachian tube (ET) orifice.
STUDY DESIGN: Prospective, case-control trial.
MATERIAL AND METHODS: Patients with persistent ETD were recruited and allocated to electrocoagulation tuboplasty and continued medical therapy groups. The ETD questionnaire-7 (ETDQ-7) score and objective parameters were compared between the groups at 6 and 12 months.
RESULTS: The proportion of patients with a decrease in ETDQ-7 scores was greater in the electrocoagulation group than in the medical therapy group at the 6-month follow-up (53.49% and 34.38%, respectively; p = .158), but the difference was not statistically significant. However, at the 12-month follow-up, there was a significantly higher proportion of patients with a decrease in ETDQ-7 scores in the electrocoagulation group (88.37% and 40.63%, respectively; p = .001). Additionally, a significant difference was observed between the groups in terms of the proportion of patients who improved 12 months after the treatment (tympanometry: 72.09% and 9.38%, respectively; p = .001; air-bone gap: 79.07% and 25.00%, respectively; p = .001; tympanic membrane status: 62.79% and 0.00%, respectively). In addition, the proportion of patients with improvements in the ET inflammation score was significantly different between the groups at 6-month (67.44% and 34.38%, respectively; p = .009) and 12-month (93.02% and 34.38%; p = .001) follow-ups. No device- or procedure-related serious adverse events were reported in any patients.
CONCLUSIONS: Electrocoagulation Eustachian tuboplasty appears to be a safe and feasible procedure for adult persistent ETD with hypertrophic mucosa disease in the ET orifice, and is superior to continued medical management alone. The improvements in ETDQ-7 and objective parameters persisted for 12 months.
STUDY DESIGN: Prospective, case-control trial.
MATERIAL AND METHODS: Patients with persistent ETD were recruited and allocated to electrocoagulation tuboplasty and continued medical therapy groups. The ETD questionnaire-7 (ETDQ-7) score and objective parameters were compared between the groups at 6 and 12 months.
RESULTS: The proportion of patients with a decrease in ETDQ-7 scores was greater in the electrocoagulation group than in the medical therapy group at the 6-month follow-up (53.49% and 34.38%, respectively; p = .158), but the difference was not statistically significant. However, at the 12-month follow-up, there was a significantly higher proportion of patients with a decrease in ETDQ-7 scores in the electrocoagulation group (88.37% and 40.63%, respectively; p = .001). Additionally, a significant difference was observed between the groups in terms of the proportion of patients who improved 12 months after the treatment (tympanometry: 72.09% and 9.38%, respectively; p = .001; air-bone gap: 79.07% and 25.00%, respectively; p = .001; tympanic membrane status: 62.79% and 0.00%, respectively). In addition, the proportion of patients with improvements in the ET inflammation score was significantly different between the groups at 6-month (67.44% and 34.38%, respectively; p = .009) and 12-month (93.02% and 34.38%; p = .001) follow-ups. No device- or procedure-related serious adverse events were reported in any patients.
CONCLUSIONS: Electrocoagulation Eustachian tuboplasty appears to be a safe and feasible procedure for adult persistent ETD with hypertrophic mucosa disease in the ET orifice, and is superior to continued medical management alone. The improvements in ETDQ-7 and objective parameters persisted for 12 months.