AbuRahma 2010.
Methods | Method of randomisation: unknown Concealment: sealed envelops that were opened just before surgery Not blind Cross‐overs: none (ITT analysis) Exclusions during trial: none Loss to follow‐up: none |
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Participants | USA 200 participants, 200 operations Routine shunting: 98 operations Selective shunting: 102 operations Age: 45 to 89 years, mean 68 years Sex: 48% male, 52% female Comparability: age, sex, vascular risk factors similar between 2 groups More asymptomatic ipsilateral arteries in routine shunting group: 58% versus 53% Contralateral artery stenosis (mean %) routine shunting group: 38%; selective shunting group: 40% | |
Interventions | Treatment: selective shunting group; shunt selected if systolic stump pressure < 40 mmHg Control: routine shunting group All operations under general anaesthetic; unknown patching rate | |
Outcomes | TIA, stroke, combined stroke/TIA, death, bleeding, myocardial infarction, congestive, heart failure, asymptomatic carotid thrombosis, recurrent laryngeal injury, all complications, number of shunted artery | |
Notes | Exclusion: none Follow‐up: 30 days | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "200 CEA patients were randomised into" |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was done using sealed envelopes that were open just before surgery" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
Selective reporting (reporting bias) | High risk | Study authors did not report prespecified outcome |
Other bias | High risk | Not reported |