| Study characteristics |
| Methods |
Allocation concealment: sealed envelopes (not opaque or numbered)
Blinding of outcome assessment: duplex and clinical FU blind
Cross‐overs: none
Exclusions during trial: participants with residual stenosis/occlusion
Participants lost to FU: none during perioperative period but unknown at the end of follow‐up |
| Participants |
Country: Germany
Number of participants: 126
Number of operations: 174
Sex: 60% male
Mean age: 64 years
% asymptomatic carotid disease: 30%
% stenosis: unknown
Comparability: age, sex, vascular risk factors and % asymptomatic disease not reported by treatment group |
| Interventions |
Treatment: autologous vein patch
Control: primary closure
% shunted: routine shunting for all
Medication: postoperative aspirin (1 g) for all |
| Outcomes |
Death within 30 days and during FU; stroke within 30 days and during FU; wound haemorrhage or infection; restenosis > 50% or occlusion at end of FU (duplex) |
| Notes |
Exclusion criteria: recurrent stenosis, kinked ICA
FU: 1 year
Funding sources: none reported |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Random sequence generation not reported. |
| Allocation concealment (selection bias) |
High risk |
Sealed envelopes but not opaque or numbered. |
| 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 |
Unclear risk |
Number of participants lost to follow‐up not reported. |
| Selective reporting (reporting bias) |
Unclear risk |
Unclear whether study authors reported the results of all prestated outcomes. |
| Other bias |
Low risk |
None suspected. |
