Skip to main content
. 2020 Apr 29;2020(4):CD011365. doi: 10.1002/14651858.CD011365.pub2

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:
  • Number randomised: 100 children randomised, 92 included in the postoperative analysis

  • Number completed: 92 children


Participant (baseline) characteristics:
  • Age: 2 to 10 years

  • Gender: 63% boys, 37% girls


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.
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
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)
Notes Participants lost to short‐term follow‐up total: 8%
Participants lost to long‐term follow‐up total: 73%
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