OBJECTIVES: To determine the adjuvant effects of adenoidectomy with short-stay ventilation tubes to hearing and revision surgery in children over 3.5 years with persistent otitis media with effusion. DESIGN: Randomised controlled three armed trial: observation, short-stay ventilation tube or ventilation tubes with adjuvant adenoidectomy. Five follow-up visits over 2 years. SETTING:Eleven UK Otorhinolaryngology Departments. PARTICIPANTS: Children with bilateral otitis media with effusion and better ear hearing level (HL) ≥20 dB persistent for 3 months. Of the 425 eligible children, 376 (88%) accepted randomisation. MAIN OUTCOME MEASURES: Pure-tone hearing thresholds, eligibility for and actual revision surgery rates, otoscopic sequelae and complications of adenoidectomy. RESULTS: Loss to follow-up at 3, 12 and 24 months was 2%, 6% and 5% respectively. Of the 376 randomised children, 253 (67%) had complete data for all five follow-up visits. Adenoidectomy did not add to the benefit to hearing thresholds of ventilation tubes of 8.8 dB (CI: 7.1-10.5) averaged over 3-6 months postoperatively. Averaged over 12, 18 and 24 months, adenoidectomy provided 4.2 dB of benefit (CI: 2.6-5.7) whilst ventilation tubes gave no benefit. Standardised effect sizes through two years showed equal benefit from ventilation tubes (0.50 sd) and adenoidectomy (0.61 sd) which are additive (1.11 sd). Adenoidectomy halved the numbers meeting a 25 dB HL bilateral cut-off for eligibility for repeat tube surgery from 31% to 14% at 12 months and from 33% to 15% at 18 months. The actual reduction in re-insertion surgery (absolute risk difference) was 21%. In tubed ears, tympanosclerosis occurred in 27%, but otorrhoea in only <2% and permanent perforations in <1%. These events did not occur in control ears. In children that had adenoidectomy, one of 165 (0.6%) had haemorrhage that required return to theatre. CONCLUSIONS:Adjuvant adenoidectomy doubles benefit from short-stay ventilation tubes by extending better hearing through the second year in children aged 3.25-6.75 years with persistent otitis media with effusion with at least a 20 dB HL in both ears. The duration of benefit of adenoidectomy is related to the duration of function of the type of the ventilation tubes used. Adenoidectomy also substantially reduces eligibility for revision surgery.
RCT Entities:
OBJECTIVES: To determine the adjuvant effects of adenoidectomy with short-stay ventilation tubes to hearing and revision surgery in children over 3.5 years with persistent otitis media with effusion. DESIGN: Randomised controlled three armed trial: observation, short-stay ventilation tube or ventilation tubes with adjuvant adenoidectomy. Five follow-up visits over 2 years. SETTING: Eleven UK Otorhinolaryngology Departments. PARTICIPANTS: Children with bilateral otitis media with effusion and better ear hearing level (HL) ≥20 dB persistent for 3 months. Of the 425 eligible children, 376 (88%) accepted randomisation. MAIN OUTCOME MEASURES: Pure-tone hearing thresholds, eligibility for and actual revision surgery rates, otoscopic sequelae and complications of adenoidectomy. RESULTS: Loss to follow-up at 3, 12 and 24 months was 2%, 6% and 5% respectively. Of the 376 randomised children, 253 (67%) had complete data for all five follow-up visits. Adenoidectomy did not add to the benefit to hearing thresholds of ventilation tubes of 8.8 dB (CI: 7.1-10.5) averaged over 3-6 months postoperatively. Averaged over 12, 18 and 24 months, adenoidectomy provided 4.2 dB of benefit (CI: 2.6-5.7) whilst ventilation tubes gave no benefit. Standardised effect sizes through two years showed equal benefit from ventilation tubes (0.50 sd) and adenoidectomy (0.61 sd) which are additive (1.11 sd). Adenoidectomy halved the numbers meeting a 25 dB HL bilateral cut-off for eligibility for repeat tube surgery from 31% to 14% at 12 months and from 33% to 15% at 18 months. The actual reduction in re-insertion surgery (absolute risk difference) was 21%. In tubed ears, tympanosclerosis occurred in 27%, but otorrhoea in only <2% and permanent perforations in <1%. These events did not occur in control ears. In children that had adenoidectomy, one of 165 (0.6%) had haemorrhage that required return to theatre. CONCLUSIONS: Adjuvant adenoidectomy doubles benefit from short-stay ventilation tubes by extending better hearing through the second year in children aged 3.25-6.75 years with persistent otitis media with effusion with at least a 20 dB HL in both ears. The duration of benefit of adenoidectomy is related to the duration of function of the type of the ventilation tubes used. Adenoidectomy also substantially reduces eligibility for revision surgery.