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. 2023 Nov 15;2023(11):CD015215. doi: 10.1002/14651858.CD015215.pub2

Tao 2020.

Study characteristics
Methods 2‐arm, randomised, parallel‐group, open, controlled trial with 12 months of follow‐up
Randomised by child
Participants Location: China, single centre
Setting of recruitment and treatment: ENT Department, Guangzhou Women and Children's Medical Center
Study dates: January 2016 to June 2018
Sample size:
  • Number randomised: 178 (90 in VT plus adenoidectomy group, 88 in myringotomy plus adenoidectomy group)

  • Number completed: 169 (87 in VT plus adenoidectomy group, 82 in myringotomy plus adenoidectomy group)


Participant (baseline) characteristics:
Age (years): VT plus adenoidectomy mean 7.0 (SD 1.9) years; LM plus adenoidectomy mean 7.2 (SD 2.4) years
Gender: VT males 42/87 (48%), females 45/87 (52%); LM males 42/82 (51%), females 40/82 (49%)
Inclusion criteria:
  • Bilateral otitis media with effusion diagnosed by air‐drum otoscopy and confirmed by acoustic impedance examination (Type B)

  • Electronic nasopharyngoscopy‐confirmed adenoid hypertrophy blocking more than 1/2 of the posterior nares

  • Middle ear effusion persisting longer than 3 months after conservative treatment, which includes nasal corticosteroids, oral montelukast sodium, oral mucoactive agents and modified Eustachian tube insufflation, plus added antibiotics if complicated by acute sinusitis

  • Average bilateral hearing threshold exceeding 25 dB HL for 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz

  • Patients aged 4 to 12 years


Exclusion criteria:
  • A previous history of nose, ear or nasopharyngeal surgery

  • Cleft palate or other congenital malformations that may affect the state of the middle ear

  • Congenital or acquired immune deficiency

  • Sensorineural hearing loss or mixed hearing loss

Interventions Ventilation tube:
  • Myringotomy was performed to suck out the intratympanic fluid, and then a conical short‐acting silicon middle ear ventilation tube was placed


Myringotomy:
  • Myringotomy was performed under otoendoscope; the intratympanic fluid was sucked out


Interventions administered to both groups:
  • Low temperature plasma radiofrequency ablation of the adenoids was performed, which was assisted by indirect nasopharyngoscopy with entry through the mouth, taking care to avoid damage to the Torus tubarius and the pharyngeal opening of the Eustachian tube

Outcomes Persistent perforation
Persistence of OME ‐ these data were not used in the review, as data were only reported for one group at 3 months follow‐up, and data from later time points will be affected by the use of different additional treatments in each arm.
Adverse events
Funding sources Not reported
Declarations of interest
Notes Research integrity checklist:
No retraction notices or expressions of concern were noted
No prospective trial registration was identified
Baseline characteristics were not excessively similar between the two groups
Plausible loss to follow‐up was reported
No implausible results were found
Different numbers of participants were allocated to each group
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk “All patients were randomly divided into two groups, namely Group A and B, according to the sequence generated by a computer program when they were admitted to the hospital.”
Allocation concealment (selection bias) Unclear risk Insufficient information to assess.
Blinding of participants and personnel (performance bias)
All outcomes High risk There was no report of blinding. Blinding of patients and personnel may not have been feasible for operative interventions. However, lack of blinding could influence outcomes.
Blinding of outcome assessment (detection bias)
All outcomes High risk There was no report of blinding. Blinding of patients and personnel may not have been feasible for operative interventions. However, lack of blinding could influence outcome interpretation.
Incomplete outcome data (attrition bias)
All outcomes Low risk Low attrition rate.
Selective reporting (reporting bias) Unclear risk No protocol was available to assess.
Other bias Unclear risk Insufficient detail in the report to assess whether an important risk of bias exists.