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. 2020 Apr 29;2020(4):CD011365. doi: 10.1002/14651858.CD011365.pub2

Korkmaz 2008.

Study characteristics
Methods Non‐blinded, parallel‐group randomised controlled surgical trial with 2‐year duration of follow‐up
Participants Setting: secondary care hospital, Trabzon, Turkey
Sample size:
  • Number randomised: 104 randomised (96 consented, 81 included in study)

  • Number completed: 68 children


Participant (baseline) characteristics:
  • Age: 2 to 14 years

  • Gender: quoted for the 81 who were analysed; 60% males, 40% females


Inclusion criteria: children diagnosed with obstructive tonsilla palatina; obstructive problems due to the tonsillar palatina hypertrophy were based on the history provided by the child's caregiver (snoring, apnoea, restless sleep, frequent awakenings and bed wetting). Diagnosis of the obstructive tonsils were confirmed by the physician by physical examination (tonsils occupying more than 75% of the space between anterior pillars).
Exclusion criteria: patients with documented recurrent tonsillitis disease, patients with a history of acute tonsillitis in the previous 3 weeks, patients with active infection, patients with additional health problems
Interventions Intervention group: classical dissection tonsillectomy (TE) (n = 41)
Comparator group: intracapsular partial tonsillectomy (TT) (n = 40)
Use of additional interventions: adenoidectomy where required, no figure quoted
Outcomes Short‐term outcomes (10 days): postoperative pain, operation time, intraoperative blood loss, postoperative nausea, postoperative otalgia, postoperative infection, postoperative haemorrhage, postoperative quality of life (VAS), postoperative daily activity (VAS)
Long‐term outcome (2 years): tonsil re‐growth
Notes Participants lost pre‐trial total: 8% pre‐trial dropout (method of Zelen; 8 declined participation)
Participants lost to short‐term follow‐up total: 16% excluded from the analysis
Participants lost to long‐term follow‐up: 29% completed the 2‐year follow‐up
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The children .... were alternatively allocated ..."
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% pre‐trial dropout (method of Zelen; 8 declined participation post‐randomisation)
16% of patients lost to short‐term follow‐up
29% of patients lost to long‐term follow‐up
Selective reporting (reporting bias) High risk No mention of demographics for the 96 consented, only the 81 analysed
No mention of vomiting in the results
VAS scores seemed to be combined but are meant to refer to quality of life and daily activity – not reported separately
Other bias High risk Baseline characteristics: not balanced for gender in tonsillectomy group (M 69%:F 31%)
ITT analysis: not performed
Formal sample size calculations: not performed
Use of co‐interventions: not stated across groups