Kordeluk 2016.
Study characteristics | ||
Methods | Double‐blinded, parallel‐group randomised controlled trial with 6‐month duration of follow‐up | |
Participants |
Setting: Soroka University Medical Center (SUMC), tertiary hospital, Southern Israel Sample size:
Participant (baseline) characteristics:
Inclusion criteria: clinical history of OSDB (snoring and apnoea) and if physical exam showed tonsil size to be +3 according to Brodsky grading or more (extending past halfway between the anterior pillar and the uvula) with enlarged adenoids as seen either by endoscopy or X‐ray Exclusion criteria: patients with a history of recurrent tonsillitis and peritonsillar abscess, where a partial tonsillectomy may not be appropriate in addition. Patients with craniofacial abnormalities or neuromuscular disorders. |
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Interventions |
Intervention group: standard tonsillectomy (TE) using electrocautery (n = 34) Comparator group: partial intracapsular tonsillectomy (TT) using laser (n = 30) or microdebrider (n = 28); (n = 58) Use of additional interventions: concurrent adenoidectomy performed in all participants |
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Outcomes |
Short‐term outcomes (24 hours): inflammation (CRP, WBC, NEU, IL‐6 and TNF‐alpha) and bleeding Short‐term outcomes (1 week): postoperative pain, swallowing, analgesic use and snoring Long‐term outcomes (3 to 6 months): respiratory events during sleep (Apnoea‐Hypopnea Index, AHI) |
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Notes |
Participants lost to short‐term follow‐up total: 8% Participants lost to long‐term follow‐up total: 73% |
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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 into three groups in four strata of age 2–4, 4–6, 6–8, 8–10" |
Allocation concealment (selection bias) | Unclear risk | Quote: "We conducted a randomized controlled trial (RCT)"; no further details provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The study was double‐blind; the patients and caregivers did not know before surgery until the first appointment (7 days after surgery) what type of surgery would be performed" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the lab technicians performing the testing were not aware of the group assignment" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 8% loss to follow‐up 73% loss to follow‐up for polysomnography data |
Selective reporting (reporting bias) | Low risk | Clinical Trials Registration #NCT01319058 |
Other bias | Low risk | Baseline characteristics: balanced ITT analysis: performed Formal sample size calculations: performed Use of co‐interventions: balanced, all children received concurrent adenoidectomy |