Skip to main content
. 2020 Apr 29;2020(4):CD011365. doi: 10.1002/14651858.CD011365.pub2

Li 2013.

Study characteristics
Methods Non‐blinded, parallel‐group randomised controlled surgical trial with 6‐month duration of follow‐up
Participants Setting: Center Hospital Dalian, China
Sample size:
  • Number randomised: 160 children

  • Number completed: 147 children


Participant (baseline) characteristics:
  • Age: 2 to 13 years

  • Gender: 56% males, 44% females


Inclusion criteria: diagnosis of OSAHS according to the Urumqi 2007 criteria produced by the Chinese Otolaryngology Research Team
Exclusion criteria: not stated
Interventions Intervention group: tonsillectomy (TE) using coblation (n = 80)
Comparator group: tonsillotomy (TT) using coblation (n = 80)
Use of additional interventions: concurrent adenoidectomy in all participants
Outcomes Short‐term outcomes (1 week and 3 months): sleep monitoring results (looking at snoring/apnoea, lowest oxygen saturation and mean oxygen saturation), postoperative pain according to VAS and therapeutic effects (e.g. postoperative bleeding)
Medium‐term outcomes (6 months): recurrence of oSDB symptoms
Notes Participants lost to medium‐term follow‐up (6 months) total: 8% (10% TE, 6% TT)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method not described
Allocation concealment (selection bias) Unclear risk Method not described
Blinding of participants and personnel (performance bias)
All outcomes High risk Not blinded
Blinding of outcome assessment (detection bias)
All outcomes High risk Not blinded
Incomplete outcome data (attrition bias)
All outcomes High risk 8% patients lost to follow‐up
Selective reporting (reporting bias) Unclear risk No protocol available; insufficient information to permit a judgement of low or high risk
Other bias Unclear risk Participant base characteristics: balanced
Formal sample size calculations: not performed
ITT analysis: unclear
Use of co‐interventions: similar across groups (concurrent adenoidectomy performed in 100% TE, 100% TT)