OBJECTIVE:Complications after ventilation tube insertion for middle ear effusion in patients with nasopharyngeal carcinoma are frequent. This may compromise the overall benefit obtained from the procedure. This study evaluates the hearing improvement after tube insertion compared with observation alone to see if the benefits of the procedure outweigh its potential complications. DESIGN: Prospective randomized controlled trial. SETTING:Full clinical and emergency otolaryngologic services hospital in an academic institution. METHODS:Patients with nasopharyngeal carcinoma and middle ear effusion were randomized for preradiotherapy ventilation tube insertion or observation. Audiologic assessment with a pure-tone audiogram was performed before the procedure, after ventilation tube insertion, and at fixed intervals after irradiation. Audiologic outcome was compared between the two groups. MAIN OUTCOME MEASURE: Air-conduction threshold and air-bone gap on a pure-tone audiogram at different intervals after radiotherapy. RESULTS: There was no significant difference in hearing threshold changes between the two groups for up to 4 years. Both groups had air-bone gap improvement following radiotherapy and the improvement was not significantly different between the two groups. The proportion of patients with closure of the air-bone gap on follow-up was not different between the two groups. CONCLUSIONS:Ventilation tube insertion before radiotherapy did not offer additional hearing benefit when compared with observation alone. The procedure had no deleterious effect on hearing for up to 4 years.
RCT Entities:
OBJECTIVE: Complications after ventilation tube insertion for middle ear effusion in patients with nasopharyngeal carcinoma are frequent. This may compromise the overall benefit obtained from the procedure. This study evaluates the hearing improvement after tube insertion compared with observation alone to see if the benefits of the procedure outweigh its potential complications. DESIGN: Prospective randomized controlled trial. SETTING: Full clinical and emergency otolaryngologic services hospital in an academic institution. METHODS:Patients with nasopharyngeal carcinoma and middle ear effusion were randomized for preradiotherapy ventilation tube insertion or observation. Audiologic assessment with a pure-tone audiogram was performed before the procedure, after ventilation tube insertion, and at fixed intervals after irradiation. Audiologic outcome was compared between the two groups. MAIN OUTCOME MEASURE: Air-conduction threshold and air-bone gap on a pure-tone audiogram at different intervals after radiotherapy. RESULTS: There was no significant difference in hearing threshold changes between the two groups for up to 4 years. Both groups had air-bone gap improvement following radiotherapy and the improvement was not significantly different between the two groups. The proportion of patients with closure of the air-bone gap on follow-up was not different between the two groups. CONCLUSIONS: Ventilation tube insertion before radiotherapy did not offer additional hearing benefit when compared with observation alone. The procedure had no deleterious effect on hearing for up to 4 years.