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. |