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

Ericsson 2009.

Study characteristics
Methods Non‐blinded, parallel‐group randomised controlled surgical trial with 2‐year duration of follow‐up
Participants Setting: 1 university clinic, 2 county council hospitals, Sweden
Sample size:
  • Number randomised: 118 randomised (36 declined participation, 4 excluded due to randomisation error, 7 excluded due to exclusion criteria, 71 children included in study)

  • Number completed: 67 children


Participant (baseline) characteristics:
  • Age: 4.5 to 5.5 years

  • Gender: 58% males, 42% females


Inclusion criteria: tonsil hypertrophy and sleep disordered breathing with or without recurrent tonsillitis as determined by otolaryngologist and listed for tonsil surgery
Exclusion criteria: antibiotics for throat infection in past 3 months, prior treatment for peritonsillitis, record of small tonsils, complicating disease requiring special care, inability to speak Swedish, obesity and bleeding disorder
Interventions Intervention group: cold knife tonsillectomy (TE) with blunt dissection (n = 32)
Comparator group: radiofrequency tonsillotomy (TT) of protruding part of tonsils, removed to region parallel to tonsillar pillars (n = 35)
Use of additional interventions: 80% had concurrent adenoidectomy; TE 78%, TT 80%
Outcomes Short‐term outcomes (6 months): postoperative pain, postoperative bleeding, analgesic use, return to normal diet, return to normal activity, disease‐specific quality of life (OSA‐18), behaviour (Child Behaviour Checklist, CBCL), general health (questionnaire), oSDB symptom recurrence, infection rate
Long‐term (2 years): disease‐specific quality of life (OSA‐18), behaviour (Child Behaviour Checklist, CBCL), general health (questionnaire), oSDB symptom recurrence, infection rate, dentofacial morphology and growth
Notes Participants lost pre‐trial total: 40% pre‐trial dropout (method of Zelen; 36 declined participation, 4 excluded due to randomisation error, 7 excluded due to exclusion criteria)
Participants lost to short‐term follow‐up: 6% dropout before 6 months (3 spontaneous recovery and 1 declined surgery).
Participants lost to long‐term follow‐up: 4% dropout at 2 years (3 did not attend ENT examination)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The children were initially randomized from the existing ordinary waiting list for tonsil surgery either to tonsillotomy using radiofrequency technique or to regular Tonsillectomy (TE), according the method of Zelen"
Allocation concealment (selection bias) Low risk Quote: "The randomization procedure was implemented using a computer generated sequentially numbered list. An independent person drew from this list and assigned even numbers to TT and odd numbers to TE."
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 40% pre‐trial dropout (method of Zelen; 36 declined participation, 4 excluded due to randomisation error, 7 excluded due to exclusion criteria)
6% loss to short‐term (6 months) follow‐up
4% loss to long‐term (2 year) follow‐up
Selective reporting (reporting bias) High risk 11‐item questionnaire not fully reported
Other bias Unclear risk Baseline characteristics: not balanced for gender in tonsillectomy group (M 69%:F 31%)
ITT analysis: performed
Formal sample size calculations: performed
Use of co‐interventions: similar across groups (concurrent adenoidectomy performed in 78% TE, 80% TT)