Hultcrantz 2004.
Study characteristics | ||
Methods | Non‐blinded (open‐label), parallel‐group randomised controlled surgical trial with 3‐year duration of follow‐up | |
Participants |
Setting: 3 otolaryngology clinics (1 university clinic and 2 otolaryngology clinics at local hospitals) in Sweden Sample size:
Participant (baseline) characteristics:
Inclusion criteria: children on the waiting list for tonsillectomy because of obstructive problems due to tonsil hypertrophy with or without recurrent tonsillitis (approximately 60% of children in both groups had more than one episode of tonsil infection) Exclusion criteria: children who had had peri‐tonsillitis, those with small tonsils and those who no longer fulfilled the criteria for surgery |
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Interventions |
Intervention group: tonsillectomy (TE) by cold knife and blunt dissection (n = 43) Comparator group: tonsillotomy (TT) using radiofrequency technique (n = 49) Use of additional interventions: concurrent adenoidectomy performed in 49% of children |
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Outcomes |
Short‐term outcomes (10 days): intraoperative blood loss, postoperative bleeding events, postoperative infections, weight, anxiety, postoperative pain, dietary intake, snoring Long‐term outcomes (1 year): general health, snoring, eating difficulties, infections using the Qu1 questionnaire and the Child Behaviour Checklist (CBCL), reoperation rates, tonsil regrowth, parental satisfaction Long‐term outcomes (3 years): generic health‐related quality of life using the Glasgow Children's Benefit Inventory (GCBI), snoring, eating difficulties, number of ENT infections using the Qu1 questionnaire, reoperation rates, tonsil regrowth, parental satisfaction |
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Notes |
Participants lost pre‐trial total: 22% pre‐trial dropout (method of Zelen; 22 declined participation, 11 excluded due to exclusion criteria) Participants lost to short‐term follow‐up: 21% dropout (24 spontaneous recovery so not operated on) Participants lost to long‐term follow‐up: 0% dropout at 1 and 3 years |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The randomization was performed according to a modification of Zelen's method" |
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 | 22% pre‐trial dropout (method of Zelen; 22 declined participation, 12 excluded due to exclusion criteria) 21% loss to short‐term (10 days) follow‐up due to spontaneous recovery pre‐surgery 0% loss to long‐term (2‐year) 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 | Baseline characteristics: not balanced for gender in tonsillotomy group (M 39%:F 61%) Unclear whether ITT analysis was performed Formal sample size calculations: performed Use of co‐interventions: similar across groups; concurrent adenoidectomy performed in 44% TE and 53% TT |