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Adjuvant adenoidectomy in persistent bilateral otitis media with effusion: hearing and revision surgery outcomes through 2 years in the TARGET randomised trial.
Clin Otolaryngol 2012; 37(2):107-16CO

Abstract

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.

Authors+Show Affiliations

MRC Scottish Section Institute of Hearing Research, Glasgow, UK.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22443163

Citation

MRC Multicentre Otitis Media Study Group. "Adjuvant Adenoidectomy in Persistent Bilateral Otitis Media With Effusion: Hearing and Revision Surgery Outcomes Through 2 Years in the TARGET Randomised Trial." Clinical Otolaryngology : Official Journal of ENT-UK ; Official Journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery, vol. 37, no. 2, 2012, pp. 107-16.
MRC Multicentre Otitis Media Study Group. Adjuvant adenoidectomy in persistent bilateral otitis media with effusion: hearing and revision surgery outcomes through 2 years in the TARGET randomised trial. Clin Otolaryngol. 2012;37(2):107-16.
MRC Multicentre Otitis Media Study Group. (2012). Adjuvant adenoidectomy in persistent bilateral otitis media with effusion: hearing and revision surgery outcomes through 2 years in the TARGET randomised trial. Clinical Otolaryngology : Official Journal of ENT-UK ; Official Journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery, 37(2), pp. 107-16. doi:10.1111/j.1749-4486.2012.02469.x.
MRC Multicentre Otitis Media Study Group. Adjuvant Adenoidectomy in Persistent Bilateral Otitis Media With Effusion: Hearing and Revision Surgery Outcomes Through 2 Years in the TARGET Randomised Trial. Clin Otolaryngol. 2012;37(2):107-16. PubMed PMID: 22443163.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adjuvant adenoidectomy in persistent bilateral otitis media with effusion: hearing and revision surgery outcomes through 2 years in the TARGET randomised trial. A1 - ,, PY - 2012/3/27/entrez PY - 2012/3/27/pubmed PY - 2012/9/19/medline SP - 107 EP - 16 JF - Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery JO - Clin Otolaryngol VL - 37 IS - 2 N2 - 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. SN - 1749-4486 UR - https://www.unboundmedicine.com/medline/citation/22443163/Adjuvant_adenoidectomy_in_persistent_bilateral_otitis_media_with_effusion:_hearing_and_revision_surgery_outcomes_through_2_years_in_the_TARGET_randomised_trial_ L2 - https://doi.org/10.1111/j.1749-4486.2012.02469.x DB - PRIME DP - Unbound Medicine ER -