Beriat 2013.
Study characteristics | ||
Methods | Non‐blinded, parallel‐group randomised controlled surgical trial with 1‐year duration of follow‐up | |
Participants |
Setting: Bulanik State Hospital, Turkey Sample size:
Participant (baseline) characteristics:
Inclusion criteria: children who suffer from snoring, evidenced apnoea, sleeping with mouth open. Diagnosis was "obstructed airway" according to tonsil hypertrophy based upon the information given by parents and clinical inspection. Exclusion criteria: children with successive streptococcal tonsillitis attack more than 3 times within 2 years; peritonsillar abscess history; chronic infected tonsillitis during consultation (upon pressure, tonsils generates pus); obese children who possibly have complex obstructive sleep apnoea syndrome; craniofacial abnormalities and coagulopathy |
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Interventions |
Intervention group: tonsillectomy by conventional cold steel dissection (TE) (n = 45) Comparator group: intracapsular tonsillotomy (TT) using microdebrider (n = 37) Use of additional interventions: none stated |
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Outcomes |
Short‐term outcomes (2 weeks): intraoperative blood loss, operation time, postoperative pain, analgesic use, otalgia, sore throat, transition to painless oral nutrition Long‐term outcomes (1 year): throat infections |
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Notes |
Participants lost to short‐term follow‐up total: 0% Participants lost to long‐term follow‐up total: 0% |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Through random selection"; no further information provided |
Allocation concealment (selection bias) | Unclear risk | Quote: "Through random selection"; no further information provided |
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 | Unclear risk | No loss to follow‐up in short term; not stated for long term |
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: balanced ITT analysis: performed Formal sample size calculations: not performed Use of co‐interventions: not performed |