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. 2022 Aug 3;2022(8):CD000160. doi: 10.1002/14651858.CD000160.pub4

Myers 1994.

Study characteristics
Methods Allocation concealment: opaque, sequentially numbered sealed envelopes (arteries randomised)
Blinding of outcome assessment: duplex blind, clinical FU not blind
Cross‐overs: none
Exclusions during trial: none
Participants lost to FU: 6 patch, 8 no patch (11%)
Participants Country: USA
Number of participants: 109
Number of operations: 126
Sex: 99% male
Mean age: 62 years
% asymptomatic carotid disease: 23%
% stenosis: unknown
Comparability: age, sex, vascular risk factors and % asymptomatic disease similar in each group
Interventions Treatment: saphenous vein patch
Control: primary closure
% shunted: routine shunt for all
Medication: peri‐ and postoperative aspirin (325 mg) for all
Outcomes Death within 30 days and during FU; stroke within 30 days and during FU; perioperative occlusion (ocular pneumoplethysmography); wound haemorrhage, infection or cranial nerve palsy; restenosis > 50% or occlusion at end of FU (duplex)
Notes Exclusion criteria: ICA diameter < 5 mm, arteriotomy > 3 cm, looped or kinked ICA
FU: 4 to 5 years
Funding sources for the study: none reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Sequentially numbered (arteries randomised).
Allocation concealment (selection bias) Low risk Opaque sealed envelopes.
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding of study participants not reported. Because of the nature of the intervention (patch or primary closure), the surgeon could not be blinded.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Blinding of outcome assessment not reported.
Incomplete outcome data (attrition bias)
All outcomes High risk 11% of participants lost to follow‐up.
Selective reporting (reporting bias) Unclear risk Unclear whether study authors reported the results of all prestated outcomes.
Other bias Low risk None suspected.