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:
Participant (baseline) characteristics:
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 |
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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 |
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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 |
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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 |
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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 |